Medtronic received information via literature regarding pediatric extracorporeal membrane oxygenation (ecmo).All patients received an intravenous single dose of unfractionated heparin (ufh) prior to cannulation.One patient (#6) was treated with four medtronic b io-medicus cannulae (serial numbers not provided).Patient 6 needed circuit change due to clot and fibrin formation into the return cannulae with rising d-dimer levels despite anti-xa levels within range.The patient had a retained cannula remnant in the external iliac artery.This patient was conservatively managed with limb preservation after multidisciplinary discussions which balanced the risk of exposure to further complications from a reperfusion cannula which was unlikely to improve distal limb perfusion, anticoagulation, and trajectory of underlying clinical course.No additional adverse patient effects or product performance issues were reported.
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Literation information: authors: ignat t, desai a, hoschtitzky a, smith r, jackson t, frall d, evans e, trimlett r, ledot s, chan-dominy a.Title of article: cardiohelp system use in school age children and adolescents at a center with interfacility mobile extracorporeal membrane oxygenation capability.Journal: int j artif organs.2022 feb;45(2):134-139.Doi: 10.1177/0391398821990659.Epub 2021 feb 2.Pmid: 33530844.E-published date used for event date in b3.No unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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