MEDTRONIC HEART VALVES DIVISION MEDTRONIC TRANSCATHETER VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
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Model Number MDT-TRANS VALVE |
Device Problems
Gradient Increase (1270); Perivalvular Leak (1457); Inadequacy of Device Shape and/or Size (1583); 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); Myocardial Infarction (1969); Rupture (2208); Heart Failure/Congestive Heart Failure (4446); Valvular Insufficiency/ Regurgitation (4449); Aortic Valve Insufficiency/ Regurgitation (4450)
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Event Date 09/05/2023 |
Event Type
Injury
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Manufacturer Narrative
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Citation: leone et al.Prosthesis-patient mismatch after transcatheter implantation of contemporary balloon-expandable and self-expandable valves in small aortic annuli.Catheter cardiovasc interv.2023 nov;102(5):931-943.Doi: 10.1002/ccd.30818.Epub 2023 sep 5.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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Event Description
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Literature was reviewed regarding prosthesis-patient mismatch after transcatheter implantation in small aortic annuli. the study population included 628 patients with a mean age of 83 years who were predominantly female. multiple manufacturer¿s devices were implanted in the study population; 274 patients were implanted with a medtronic evolut r or evolut pro 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: patient-prosthesis mismatch, moderate to severe aortic regurgitation, moderate to severe paravalvular leak, annular rupture, vascular complication, bleeding complication, arrhythmia requiring permanent pacemaker implant, transvalvular gradients >20 mmhg, myocardial infarction, stroke, acute kidney injury, congestive heart failure requiring hospitalization. no further information was provided pertaining to medtronic products.
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