Citation: kratochvilova et al.Might simplification of transcatheter aortic valve implantation reduce the burden on hospital resources? eur heart j suppl.2022 mar 30;24(suppl b):b28-b35.Doi: 10.1093/eurheartjsupp/suac009.Ecollection 2022 apr.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.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.
|
Medtronic received information via literature regarding transcatheter aortic valve implantation burden on hospital resources. all data were collected from a single center from april 2018 thru march 2021. the study population included 214 patients who were predominantly female with a mean weight of 80 kg. multiple manufacturer¿s devices were implanted in the study population; 203 patients were implanted with a medtronic evolut r bioprosthetic valve.No unique device identifier numbers were provided. among all patients, adverse events included: moderate to severe aortic regurgitation (ar), bleeding, and arrhythmia requiring permanent pacemaker implant.Based on the available information medtronic product was associated with the adverse events. no additional adverse patient effects or product performance issues were reported.
|