MEDTRONIC HEART VALVES DIVISION COREVALVE TRANSCATHETER AORTIC VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
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Model Number CRS |
Device Problems
Difficult or Delayed Positioning (1157); Perivalvular Leak (1457); Patient Device Interaction Problem (4001); Central Regurgitation (4068)
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Patient Problems
Stroke/CVA (1770); Non specific EKG/ECG Changes (1817); Hemorrhage/Bleeding (1888); Cardiac Tamponade (2226); Valvular Insufficiency/ Regurgitation (4449); Aortic Valve Insufficiency/ Regurgitation (4450)
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Event Date 01/17/2024 |
Event Type
Injury
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Event Description
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Literature was reviewed regarding single-center experience with a balloon-expandable non-medtronic transcatheter aortic valve in patients with bicuspid anatomy.The study population included 269 patients with a mean age of 75 years who were predominantly male. multiple manufacturer¿s devices were implanted in the study population; an undisclosed number of patients were implanted with a medtronic corevalve bioprosthetic valve. deaths occurred in the study population; however, there was no statement establishing a causal or contributory relationship between medtronic product and the deaths. among all patients adverse events included: stroke, acute kidney injury, major vascular complication, arrhythmia requiring permanent pacemaker implant, cardiac tamponade, valve malposition, life-threatening bleeding complication, moderate to severe aortic regurgitation, and moderate to severe paravalvular leak. no further information was provided pertaining to medtronic products.
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Manufacturer Narrative
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Citation: magyari et al.Single-center experience with the balloon-expandable myval transcatheter aortic valve system in patients with bicuspid anatomy: procedural and 30-day follow-up.J clin med.2024 jan 17;13(2):513.Doi: 10.3390/jcm13020513.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.
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