MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION MEDTRONIC TRANSCATHETER VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV

Model Number MDT-TRANS VALVE

Device Problem Perivalvular Leak (1457)

Patient Problems Stroke/CVA (1770); Non specific EKG/ECG Changes (1817); Hemorrhage/Bleeding (1888); Valvular Insufficiency/ Regurgitation (4449)

Event Date 11/12/2021

Event Type  Injury  

Manufacturer Narrative

Citation: guddeti r.; et al.Transcatheter aortic valve replacement in mixed aortic valve disease: a systematic review and meta-analysis.Eur heart j qual care clin outcomes.2022 mar 2;8(2):169-176.Doi: 10.1093/ehjqcco/qcab080.Pmid: 34788825.Online publish-ahead-of-print 12 november 2021.Earliest date of publication used for date of event.Medtronic products referenced: corevalve, evolut r (pma# p130021, product code: npt).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.

Event Description

Medtronic received information via literature regarding transcatheter aortic valve replacement (tavr) in patients with mixed aortic stenosis/insufficiency.All data were collected from a meta-analysis review.The study population among the six articles in the review included 58,879 patients who were predominantly male with a mean age of 83 years.Multiple manufacturer¿s devices were implanted in the study population; in four of the studies, some patients were implanted with a medtronic corevalve or evolut r bioprosthetic valve.No unique device identifier numbers were provided.Among all patients, all-cause pooled mortality was 18.9%.No further details were provided on the deaths.There was no statement of causal or contributory relationship between medtronic product and the deaths.Among all patients, adverse events included: moderate-severe aortic paravalvular leaks, strokes, major bleeding, vascular complications and need for permanent pacemaker implantation.Based on the available information medtronic product may have been associated with the adverse events.No additional adverse patient effects or product performance issues were reported.

• Brand Name: MEDTRONIC TRANSCATHETER VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 16402389
• MDR Text Key: 309906503
• Report Number: 2025587-2023-00597
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MDT-TRANS VALVE
• Device Catalogue Number: MDT-TRANS VALVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 83 YR
• Patient Sex: Male