Literature details: title: strategies and techniques for percutaneous veno-arterial ecmo cannulation and decannulation in children authors: buyukgoz c, sandhu h, shah s, rower k, ramakrishnan k, waller br, kiene a, knott-craig c, boston u, sathanandam s.Journal: catheter cardiovasc interv.2023 may;101(6):1088-1097.Doi: 10.1002/ccd.30649.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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Medtronic received information via literature regarding techniques used for percutaneous veno-arterial extracorporeal membrane oxygenation (va-ecmo) cannulation and decannulation in children.All data were collected from a single center between 2019 and 2021.The study population included 20 patients, all of which were treated with medtronic bio-medicus cannulae (serial numbers not provided).It was reported that patient 1 was treated with three bio-medicus cannulae; one in the left femoral artery, one in the left femoral vein, and one in the right internal jugular vein.They were subsequently transferred on ecmo to another institution where they died 4 days after decannulation from a pulmonary hypertensive event.
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