MEDTRONIC HEART VALVES DIVISION MEDTRONIC TRANSCATHETER VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
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Model Number MDT-TRANS VALVE |
Device Problem
Perivalvular Leak (1457)
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Patient Problems
Hemorrhage/Bleeding (1888); Transient Ischemic Attack (2109); Heart Block (4444); Valvular Insufficiency/ Regurgitation (4449)
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Event Date 01/05/2023 |
Event Type
Injury
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Manufacturer Narrative
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Citation: veulemans et al.Impact of different guidewires on the implantation depth using the largest self-expandable tavi device.Front cardiovasc med.2023 jan 5;9:1064916.Doi: 10.3389/fcvm.2022.1064916.Ecollection 2022.Earliest date of publication used for date of event.Medtronic products referenced: evolut r, evolut pro, and evolut pro+.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.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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Event Description
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Medtronic received information via literature regarding the impact of different guidewires on the implantation depth for transcatheter aortic valve implantation (tavi). all data were collected from four centers between 2017 and 2021. the study population included 398 patients who were predominantly male with a mean age of 80.3 years. all patients were implanted with a medtronic evolut r (n=354), evolut pro (n=42), or evolut pro+ (n=2) bioprosthetic valve. no unique device identifier numbers were provided. among all patients, adverse events included: transient ischemic attack (tia), major vascular complication, bleeding, renal failure, atrio-ventricular (av) block requiring permanent pacemaker implant, and moderate to severe paravalvular leak (pvl). 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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