BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 13796790 · Received March 17, 2022

    Report

    Report Number
    2025587-2022-00705
    Event Type
    Death
    Date Received
    March 17, 2022
    Date of Event
    September 27, 2021
    Report Date
    March 17, 2022
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: BAPAT V., ET AL. SURGICAL EXPLANTATION AFTER TAVR FAILURE: MID-TERM OUTCOMES FROM THE EXPLANT-TAVR INTERNATIONAL REGISTRY. JACC CARDIOVASC INTERV. 2021 SEP 27;14(18):1978-1991. DOI: 10.1016/J.JCIN.2021.07.015. PMID: 34556271. PUBLISHER: JACC CARDIOVASC IN TERV EARLIEST DATE OF PUBLISH USED FOR DATE OF EVENT AND DATE OF DEATH. MEDTRONIC PRODUCTS REFERENCED: COREVALVE, EVOLUT R, EVOLUT PRO/PRO+ (PMA# (B)(4), PRODUCT CODE: NPT); ENGAGER (PMA# N/A, PRODUCT CODE: N/A). 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REGARDING THE INDICATIONS AND OUTCOMES AFTER SURGICAL EXPLANTATION OF TRANSCATHETER AORTIC VALVE REPLACEMENTS (TAVR). ALL DATA WERE COLLECTED FROM AN INTERNATIONAL MULTI-CENTER CLINICAL REGISTRY BETWEEN NOVEMBER 2009 AND SEPTEMBER 2020. THE STUDY POPULATION INCLUDED 269 PATIENTS (PREDOMINANTLY MALE, MEAN AGE (B)(6) YEARS), 110 OF WHOM UNDERWENT PRIOR TAVR WITH VARIOUS MEDTRONIC SELF-EXPANDING TRANSCATHETER AORTIC BIOPROSTHETIC VALVES, INCLUDING COREVALVE, EVOLUT R, EVOLUT PRO/PRO+ AND ENGAGER MODELS (UNIQUE DEVICE IDENTIFIER NUMBERS NOT PROVIDED). AMONG ALL PATIENTS, IN-HOSPITAL, 30-DAY AND 1-YEAR POST-EXPLANT MORTALITY WAS 11.9%, 13.1% AND 28.5%, RESPECTIVELY. NO FURTHER DETAILS WERE PROVIDED. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT MAY HAVE BEEN ASSOCIATED WITH THE DEATHS. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: NEED FOR SURGICAL EXPLANTATION OF TAVR VALVES, STROKES, ENDOCARDITIS, PARAVALVULAR LEAK (PVL), STRUCTURAL VALVE DEGENERATION (SVD), PATIENT-PROSTHESIS MISMATCH (PPM), UNFAVORABLE ANATOMY, VALVE MIGRATION, AORTIC/MITRAL REGURGITATION, MITRAL STENOSIS, DECOMPENSATED HEART FAILURE AND AORTIC ANEURYSMS. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731154 MEDTRONIC TRANSCATHETER VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION MDT-TRANS VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Death UNKNOWN ICD, UNKNOWN IPG