{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,12]],"date-time":"2026-08-12T18:29:22Z","timestamp":1786559362401,"version":"build-2736575974"},"reference-count":45,"publisher":"Public Library of Science (PLoS)","issue":"8","license":[{"start":{"date-parts":[[2026,8,12]],"date-time":"2026-08-12T00:00:00Z","timestamp":1786492800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Science, Technology and Economic Commission of Shanghai Pudong New Area","award":["Contract No. 20260609-671"],"award-info":[{"award-number":["Contract No. 20260609-671"]}]}],"content-domain":{"domain":["www.plosone.org"],"crossmark-restriction":false},"short-container-title":["PLoS One"],"abstract":"<jats:sec id=\"sec001\">\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Due to differences in anatomy, coagulation and neurodevelopment, the complication rate of pediatric cardiac assist devices during use is much higher than that of adults, which cannot be directly extrapolated from adult data. Moreover, there are deficiencies in the device supervision process.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"sec002\">\n                    <jats:title>Method<\/jats:title>\n                    <jats:p>In this study, 280 adverse events of patients under 18 years old and 1,231 adverse events of adult patients were extracted from the FDA MAUDE database from 2015 to 2025. The pediatric complication spectrum was systematically analyzed, and adult data was compared with pediatric data. Combined with literature and typical case analysis, the limitations of traditional databases were jointly revealed. Finally, in accordance with the existing testing standards, the risks exposed after the product is launched on the market are summarized and the regulatory loopholes are revealed.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"sec003\">\n                    <jats:title>Result<\/jats:title>\n                    <jats:p>MAUDE pediatric reports are scarce and variables are missing, making it impossible to directly calculate the incidence rate. The research calls for the establishment of a multi-source real-time monitoring and pediatric exclusive registration system to preliminarily assess and generate hypotheses regarding the risk of mechanical circulatory support in children.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"sec004\">\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>This study provides a descriptive evaluation of reporting trend disparities between pediatric and adult cohorts. Given the inherent constraints of passive surveillance data, these exploratory findings should be interpreted as a reference to guide future prospective evaluations and standard optimizations, rather than immediate, broad regulatory mandates.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1371\/journal.pone.0355401","type":"journal-article","created":{"date-parts":[[2026,8,12]],"date-time":"2026-08-12T17:44:43Z","timestamp":1786556683000},"page":"e0355401","update-policy":"https:\/\/doi.org\/10.1371\/journal.pone.corrections_policy","source":"Crossref","is-referenced-by-count":0,"title":["Adverse event reporting and regulatory analysis of pediatric cardiac assist devices"],"prefix":"10.1371","volume":"21","author":[{"given":"Songyining","family":"Ding","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Susmitha","family":"Wunnava","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gaite","family":"Liu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hongyi","family":"Yu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sheng","family":"Hu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yaohua","family":"Li","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xinyan","family":"Zhang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peiming","family":"Zhang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yunzhang","family":"Cheng","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7798-4560","authenticated-orcid":true,"given":"Florence T.","family":"Bourgeois","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0691-4589","authenticated-orcid":true,"given":"Xun","family":"Liu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"340","published-online":{"date-parts":[[2026,8,12]]},"reference":[{"key":"pone.0355401.ref001","doi-asserted-by":"crossref","first-page":"101042","DOI":"10.1016\/j.tvir.2025.101042","article-title":"ECMO, VAD, Impella, and IABP: Primer on Mechanical Circulatory Support Devices","author":"J Kruse","year":"2025","journal-title":"Tech Vasc Interv Radiol"},{"issue":"5","key":"pone.0355401.ref002","doi-asserted-by":"crossref","DOI":"10.1542\/peds.2021-053390","article-title":"Pediatric Medical Device Development and Regulation: Current State, Barriers, and Opportunities","volume":"149","author":"J Espinoza","year":"2022","journal-title":"Pediatrics"},{"issue":"3","key":"pone.0355401.ref003","doi-asserted-by":"crossref","first-page":"428","DOI":"10.1016\/j.athoracsur.2024.11.034","article-title":"The Challenges and Opportunities in Pediatric Medical Device Innovation: Monitoring Devices","volume":"120","author":"S Duffy","year":"2025","journal-title":"Ann Thorac Surg"},{"issue":"1","key":"pone.0355401.ref004","doi-asserted-by":"crossref","first-page":"122","DOI":"10.1186\/s13019-016-0513-0","article-title":"IABP: history-evolution-pathophysiology-indications: what we need to know","volume":"11","author":"H Parissis","year":"2016","journal-title":"J Cardiothorac Surg"},{"issue":"8","key":"pone.0355401.ref005","doi-asserted-by":"crossref","first-page":"1573","DOI":"10.3390\/jcm10081573","article-title":"Use of ECMO for Cardiogenic Shock in Pediatric Population","volume":"10","author":"P Bhaskar","year":"2021","journal-title":"J Clin Med"},{"issue":"3","key":"pone.0355401.ref006","doi-asserted-by":"crossref","first-page":"329","DOI":"10.21037\/acs-2020-cfmcs-18","article-title":"Pediatric ventricular assist device registries: update and perspectives in the era of miniaturized continuous-flow pumps","volume":"10","author":"KM Lichtenstein","year":"2021","journal-title":"Ann Cardiothorac Surg"},{"issue":"1","key":"pone.0355401.ref007","first-page":"124","article-title":"A multicenter study of the impella device for mechanical support of the systemic circulation in pediatric and adolescent patients","volume":"90","author":"VV Dimas","year":"2017","journal-title":"Catheter Cardiovasc Interv"},{"key":"pone.0355401.ref008","doi-asserted-by":"crossref","first-page":"147","DOI":"10.1186\/1749-8090-6-147","article-title":"Intra aortic balloon pump: literature review of risk factors related to complications of the intraaortic balloon pump","volume":"6","author":"H Parissis","year":"2011","journal-title":"J Cardiothorac Surg"},{"issue":"13","key":"pone.0355401.ref009","doi-asserted-by":"crossref","first-page":"835","DOI":"10.21037\/atm.2020.03.152","article-title":"Complications associated with mechanical circulatory support","volume":"8","author":"JM Ali","year":"2020","journal-title":"Ann Transl Med"},{"issue":"4","key":"pone.0355401.ref010","doi-asserted-by":"crossref","first-page":"335","DOI":"10.1016\/j.hlc.2014.12.003","article-title":"Intra-aortic balloon counterpulsation in contemporary practice - where are we?","volume":"24","author":"JM White","year":"2015","journal-title":"Heart Lung Circ"},{"issue":"4","key":"pone.0355401.ref011","doi-asserted-by":"crossref","first-page":"1263","DOI":"10.1016\/j.athoracsur.2010.04.099","article-title":"Acquired von Willebrand syndrome in continuous-flow ventricular assist device recipients","volume":"90","author":"S Crow","year":"2010","journal-title":"Ann Thorac Surg"},{"key":"pone.0355401.ref012","doi-asserted-by":"crossref","DOI":"10.12659\/AJCR.941098","article-title":"Successful Treatment of Sepsis-Induced Cardiomyopathy with Intra-Aortic Balloon Pumping: A Case Report and Literature Review","volume":"24","author":"T Kuroki","year":"2023","journal-title":"Am J Case Rep"},{"issue":"5","key":"pone.0355401.ref013","doi-asserted-by":"crossref","first-page":"337","DOI":"10.1016\/j.jjcc.2024.09.009","article-title":"Clinical characteristics and short-term outcomes in patients with cardiogenic shock undergoing mechanical circulatory support escalation from intra-aortic balloon pump to impella: From the J-PVAD registry","volume":"85","author":"M Yokoi","year":"2024","journal-title":"J Cardiol"},{"issue":"3","key":"pone.0355401.ref014","doi-asserted-by":"crossref","first-page":"887","DOI":"10.1016\/S0003-4975(01)03563-9","article-title":"Current results with intraaortic balloon pumping in infants and children","volume":"73","author":"KA Pinkney","year":"2002","journal-title":"Ann Thorac Surg"},{"issue":"2","key":"pone.0355401.ref015","doi-asserted-by":"crossref","first-page":"123","DOI":"10.1007\/BF03218105","article-title":"Acute aortic thrombosis after intra-aortic balloon pumping","volume":"48","author":"Y Sakakibara","year":"2000","journal-title":"Jpn J Thorac Cardiovasc Surg"},{"issue":"4","key":"pone.0355401.ref016","doi-asserted-by":"crossref","first-page":"200","DOI":"10.1002\/clc.20975","article-title":"Intraaortic balloon pump: incidence and predictors of complications in the Florence registry","volume":"35","author":"S Valente","year":"2012","journal-title":"Clin Cardiol"},{"issue":"1","key":"pone.0355401.ref017","doi-asserted-by":"crossref","first-page":"11","DOI":"10.1097\/MAT.0000000000000290","article-title":"Incidence of Hemolysis in Patients with Cardiogenic Shock Treated with Impella Percutaneous Left Ventricular Assist Device","volume":"62","author":"AP Badiye","year":"2016","journal-title":"ASAIO J"},{"issue":"6","key":"pone.0355401.ref018","doi-asserted-by":"crossref","first-page":"1382","DOI":"10.1016\/j.jtcvs.2006.02.016","article-title":"Intra-aortic balloon pumping in children undergoing cardiac surgery: an update of the Liverpool experience","volume":"131","author":"G Kalavrouziotis","year":"2006","journal-title":"J Thorac Cardiovasc Surg"},{"issue":"4","key":"pone.0355401.ref019","doi-asserted-by":"crossref","first-page":"1012","DOI":"10.1016\/j.jtcvs.2008.11.034","article-title":"The role of cerebral hyperperfusion in postoperative neurologic dysfunction after left ventricular assist device implantation for end-stage heart failure","volume":"137","author":"K Lietz","year":"2009","journal-title":"J Thorac Cardiovasc Surg"},{"issue":"1","key":"pone.0355401.ref020","doi-asserted-by":"crossref","first-page":"54","DOI":"10.1016\/j.healun.2017.10.023","article-title":"Outcomes of children supported with devices labeled as \u201ctemporary\u201d or short term: A report from the Pediatric Interagency Registry for Mechanical Circulatory Support","volume":"37","author":"A Lorts","year":"2018","journal-title":"J Heart Lung Transplant"},{"issue":"5","key":"pone.0355401.ref021","doi-asserted-by":"crossref","first-page":"479","DOI":"10.1097\/MAT.0b013e318184e200","article-title":"Preliminary single center North American experience with the Berlin Heart pediatric EXCOR device","volume":"54","author":"SR Rockett","year":"2008","journal-title":"ASAIO J"},{"issue":"4","key":"pone.0355401.ref022","doi-asserted-by":"crossref","first-page":"439","DOI":"10.1016\/S1053-2498(00)00236-9","article-title":"Multicenter experience with the thoratec ventricular assist device in children and adolescents","volume":"20","author":"O Reinhartz","year":"2001","journal-title":"J Heart Lung Transplant"},{"issue":"19","key":"pone.0355401.ref023","doi-asserted-by":"crossref","first-page":"2313","DOI":"10.1161\/CIRCULATIONAHA.105.577601","article-title":"Outcomes of children bridged to heart transplantation with ventricular assist devices: a multi-institutional study","volume":"113","author":"ED Blume","year":"2006","journal-title":"Circulation"},{"key":"pone.0355401.ref024","doi-asserted-by":"crossref","first-page":"75","DOI":"10.1016\/j.thromres.2022.12.014","article-title":"Prevalence of hematologic complications on extracorporeal membranous oxygenation in critically ill pediatric patients: A systematic review and meta-analysis","volume":"222","author":"W Tang","year":"2023","journal-title":"Thromb Res"},{"issue":"1","key":"pone.0355401.ref025","doi-asserted-by":"crossref","first-page":"63","DOI":"10.1097\/MAT.0b013e318279854a","article-title":"Anticoagulation monitoring during pediatric extracorporeal membrane oxygenation","volume":"59","author":"MM Bembea","year":"2013","journal-title":"ASAIO J"},{"issue":"3","key":"pone.0355401.ref026","article-title":"Ventricular assist device support in children and adolescents as a bridge to heart transplantation","volume":"23","author":"A Gkouziouta","year":"2009","journal-title":"J Cardiothorac Vasc Anesth"},{"issue":"11","key":"pone.0355401.ref027","doi-asserted-by":"crossref","first-page":"1067","DOI":"10.1097\/PCC.0000000000001709","article-title":"Hemolysis During Pediatric Extracorporeal Membrane Oxygenation: Associations With Circuitry, Complications, and Mortality","volume":"19","author":"HJ Dalton","year":"2018","journal-title":"Pediatr Crit Care Med"},{"issue":"2","key":"pone.0355401.ref028","doi-asserted-by":"crossref","first-page":"153","DOI":"10.1097\/PCC.0b013e3181e2a596","article-title":"Recovery of renal function and survival after continuous renal replacement therapy during extracorporeal membrane oxygenation","volume":"12","author":"ML Paden","year":"2011","journal-title":"Pediatr Crit Care Med"},{"issue":"9","key":"pone.0355401.ref029","doi-asserted-by":"crossref","first-page":"1584","DOI":"10.1007\/s00134-013-2973-1","article-title":"Neurodevelopmental, educational and behavioral outcome at 8 years after neonatal ECMO: a nationwide multicenter study","volume":"39","author":"MJ Madderom","year":"2013","journal-title":"Intensive Care Med"},{"key":"pone.0355401.ref030","unstructured":"Surgical implants - Active implantable medical devices - Part 5: Circulatory support devices, YY\/T 0989.5-2022."},{"key":"pone.0355401.ref031","unstructured":"Implants for surgery - Active implantable medical devices - Part 5: Circulatory support devices, ISO 14708-5. 2020."},{"issue":"5","key":"pone.0355401.ref032","doi-asserted-by":"crossref","first-page":"956","DOI":"10.1007\/s43441-025-00791-1","article-title":"Keeping the End in Mind: Reviewing U.S. FDA Inspections of Submissions including Real-World Data","volume":"59","author":"C Grandinetti","year":"2025","journal-title":"Ther Innov Regul Sci"},{"issue":"6","key":"pone.0355401.ref033","doi-asserted-by":"crossref","first-page":"1356","DOI":"10.1007\/s43441-025-00827-6","article-title":"\u201cAppropriateness\u201d of Clinical Data Under Regulation (EU) 2017\/745- A Case Study and Survey","volume":"59","author":"E Oltmanns","year":"2025","journal-title":"Ther Innov Regul Sci"},{"key":"pone.0355401.ref034","doi-asserted-by":"crossref","unstructured":"Liu X, Li Y, Chen Y, Li C, Hu S. Design of a Mock Circulatory Loop with Both Systemic and Pulmonary Circulations. In: 2023 7th International Conference on Biomedical Engineering and Applications (ICBEA). IEEE; 2023. p. 115\u201324.","DOI":"10.1109\/ICBEA58866.2023.00028"},{"key":"pone.0355401.ref035","doi-asserted-by":"crossref","first-page":"188505","DOI":"10.1109\/ACCESS.2024.3491112","article-title":"Development of a Lumped Parameter Model of Human Whole Body Circulatory Loop","volume":"12","author":"X Liu","year":"2024","journal-title":"IEEE Access"},{"issue":"1","key":"pone.0355401.ref036","first-page":"70","article-title":"Methodological Study of Reliability Test of Percutaneous Ventricular Assist Device","volume":"48","author":"X Liu","year":"2024","journal-title":"Zhongguo Yi Liao Qi Xie Za Zhi"},{"issue":"3","key":"pone.0355401.ref037","doi-asserted-by":"crossref","first-page":"337","DOI":"10.1080\/14737167.2024.2431234","article-title":"Regulatory perspectives on post-market evidence generation schemes for high-risk medical devices: a systematic review","volume":"25","author":"J Aranda","year":"2025","journal-title":"Expert Rev Pharmacoecon Outcomes Res"},{"issue":"6","key":"pone.0355401.ref038","doi-asserted-by":"crossref","first-page":"467","DOI":"10.1080\/17434440.2024.2360979","article-title":"A comparative study of medical device regulation between countries based on their economies","volume":"21","author":"B Chettri","year":"2024","journal-title":"Expert Rev Med Devices"},{"issue":"10","key":"pone.0355401.ref039","doi-asserted-by":"crossref","first-page":"993","DOI":"10.1080\/17434440.2020.1825074","article-title":"Lifecycle evidence requirements for high-risk implantable medical devices: a European perspective","volume":"17","author":"R Tarricone","year":"2020","journal-title":"Expert Rev Med Devices"},{"key":"pone.0355401.ref040","doi-asserted-by":"crossref","first-page":"875","DOI":"10.3389\/fphar.2018.00875","article-title":"Detecting Pharmacovigilance Signals Combining Electronic Medical Records With Spontaneous Reports: A Case Study of Conventional Disease-Modifying Antirheumatic Drugs for Rheumatoid Arthritis","volume":"9","author":"L Wang","year":"2018","journal-title":"Front Pharmacol"},{"issue":"4","key":"pone.0355401.ref041","doi-asserted-by":"crossref","first-page":"321","DOI":"10.1007\/s40264-024-01505-6","article-title":"Leveraging Natural Language Processing and Machine Learning Methods for Adverse Drug Event Detection in Electronic Health\/Medical Records: A Scoping Review","volume":"48","author":"S Golder","year":"2025","journal-title":"Drug Saf"},{"issue":"8","key":"pone.0355401.ref042","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pcbi.1012289","article-title":"Credibility assessment of in silico clinical trials for medical devices","volume":"20","author":"P Pathmanathan","year":"2024","journal-title":"PLoS Comput Biol"},{"key":"pone.0355401.ref043","doi-asserted-by":"crossref","first-page":"1433372","DOI":"10.3389\/fmed.2024.1433372","article-title":"Toward trustworthy medical device in silico clinical trials: a hierarchical framework for establishing credibility and strategies for overcoming key challenges","volume":"11","author":"KI Aycock","year":"2024","journal-title":"Front Med (Lausanne)"},{"issue":"5","key":"pone.0355401.ref044","doi-asserted-by":"crossref","DOI":"10.1093\/pnasnexus\/pgaf123","article-title":"The future of in silico trials and digital twins in medicine","volume":"4","author":"E Samei","year":"2025","journal-title":"PNAS Nexus"},{"issue":"2","key":"pone.0355401.ref045","doi-asserted-by":"crossref","first-page":"120","DOI":"10.1016\/j.intonc.2025.03.001","article-title":"Regulatory sandbox expansion: Exploring the leap from fintech to medical artificial intelligence","volume":"1","author":"Y Qiu","year":"2025","journal-title":"Intell Oncol"}],"container-title":["PLOS One"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pone.0355401","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,8,12]],"date-time":"2026-08-12T17:44:51Z","timestamp":1786556691000},"score":1,"resource":{"primary":{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pone.0355401"}},"subtitle":[],"editor":[{"given":"Gaetano","family":"Santulli","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"editor"}]}],"short-title":[],"issued":{"date-parts":[[2026,8,12]]},"references-count":45,"journal-issue":{"issue":"8","published-online":{"date-parts":[[2026,8,12]]}},"URL":"https:\/\/doi.org\/10.1371\/journal.pone.0355401","relation":{},"ISSN":["1932-6203"],"issn-type":[{"value":"1932-6203","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,8,12]]}}}