Medtronic received information via literature comparing clinical outcomes between transcatheter and surgical aortic valve replacements (tavr and savr) for severe aortic stenosis.All data were collected from a single center between october 2015 and july 2019.The study population included 425 patients.Multiple manufacturer¿s devices were implanted in the study population; 49 patients underwent tavr using a medtronic corevalve or evolut r/pro bioprosthetic valve; 8 patients underwent savr with a mosaic ultra or avalus bioprosthetic valve; one patient underwent savr with a medtronic ats mechanical valve.No unique device identifier numbers were provided.Among all patients, freedom from all-cause deaths, strokes and re-hospitalizations was 66.2% in the savr group and 56.7% in the tavr group over a 70-month follow-up period.No further details were provided on the deaths.There was no statement of causal or contributory relationship between medtronic product and the deaths.Among all patients, adverse events included: need for intra-aortic balloon pump or extracorporeal membrane oxygenation (ecmo) post-procedure; bleeding and vascular complications requiring re-operation and blood transfusions; new-onset atrial fibrillation; cardiac conduction disturbances requiring permanent pacemaker implantation (ppmi); renal failure requiring renal replacement therapy; endocarditis; patient-prosthesis mismatch; strokes and need for re-hospitalization.Based on the available information medtronic product may have been associated with the adverse events.No additional adverse patient effects or product performance issues were reported.
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Citation: saito s.; et al.Prosthetic valve function after aortic valve replacement for severe aortic stenosis by transcatheter procedure versus surgery.J cardiovasc dev dis.2022 oct 16;9(10):355.Doi: 10.3390/jcdd9100355.Pmid: 36286307.Published: 16 october 2022 earliest date of publication used for date of event.Medtronic products referenced: corevalve, evolut r, evolut pro (pma# p130021, product code: npt); mosaic ultra (pma# p990064, product code: dye); avalus (pma# p170006, product code: lwr); ats ¿mechanical¿ (pma# p990046, product code: lwq).Earliest approved product used for product code and pma#.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.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.
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