MEDTRONIC HEART VALVES DIVISION MEDTRONIC TRANSCATHETER VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
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Model Number MDT-TRANS VALVE |
Device Problems
Perivalvular Leak (1457); Inadequacy of Device Shape and/or Size (1583)
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Patient Problems
Stroke/CVA (1770); Non specific EKG/ECG Changes (1817); Rupture (2208); Valvular Insufficiency/ Regurgitation (4449); Aortic Valve Insufficiency/ Regurgitation (4450); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/08/2022 |
Event Type
Injury
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Event Description
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Medtronic received information via literature regarding bicuspid aortic valve stenosis. the authors described a review of bioprosthetic valves and included a meta-analysis review of 10 studies published from 2016 thru 2022. multiple manufacturer¿s devices were implanted in the study population, which included medtronic evolut r or evolut pro bioprosthetic valves. no unique device identifier numbers were provided. among patients adverse events included: aortic rupture, conversion to surgery, moderate to severe aortic regurgitation and paravalvular leak (pvl), patient-prosthesis mismatch (ppm), stroke, arrhythmia requiring permanent pacemaker implant, and rehospitalization. based on the available information medtronic product was associated with the adverse events. no additional adverse patient effects or product performance issues were reported.
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Manufacturer Narrative
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Citation: perrin et al.Bicuspid aortic valve stenosis: from pathophysiological mechanism, imaging diagnosis, to clinical treatment methods.Front cardiovasc med.2022 feb 8;8:798949.Doi: 10.3389/fcvm.2021.798949.Ecollection 2021.Earliest date of publication used for date of event.No unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.Without return of the product no definitive conclusion can be made regarding the clinical observations.Select patient information cannot be included in regulatory report due to regional privacy regulations.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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