MEDTRONIC HEART VALVES DIVISION MEDTRONIC TRANSCATHETER VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
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Model Number MDT-TRANS VALVE |
Device Problems
Inadequacy of Device Shape and/or Size (1583); Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Stroke/CVA (1770); Non specific EKG/ECG Changes (1817); Hemorrhage/Bleeding (1888); Cardiovascular Insufficiency (4445); Aortic Valve Insufficiency/ Regurgitation (4450)
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Event Date 03/29/2023 |
Event Type
Injury
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Manufacturer Narrative
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Citation: ishizu et al.Impact of transjugular intracardiac echocardiography-guided self-expandable transcatheter aortic valve impl antation on reduction of conduction disturbances.Medrxiv preprint: doi.Org/10.1101/2023.03.28.23287887, posted march 29, 2023.Earliest date of publication used for date of event.Medtronic products referenced: evolut r, evolut pro or 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.Select patient information cannot be included in regulatory report due to regional privacy regulations.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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Event Description
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Literature was reviewed regarding the reduction of conduction disturbances with self-expandable transcatheter aortic valve implantation (tavi).The study population included 446 patients, all of whom were implanted with a medtronic evolut r, evolut pro or evolut pro+ bioprosthetic valve. among all patients adverse events included: valve dislodgement, stroke, major bleeding, coronary obstruction, arrhythmia requiring permanent pacemaker implant, moderate to severe aortic regurgitation, severe patient-prosthesis mismatch (ppm), need for a second valve implantation, and unspecified need for conversion to open surgery. no additional adverse patient effects were noted.
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