BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 12114496 · Received July 4, 2021

    Report

    Report Number
    2025587-2021-02096
    Event Type
    Death
    Date Received
    July 4, 2021
    Date of Event
    July 9, 2020
    Report Date
    July 4, 2021
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: RASCHPICHLER M., ET AL. VALVE-IN-VALVE FOR DEGENERATED TRANSCATHETER AORTIC VALVE REPLACEMENT VERSUS VALVE-IN-VALVE FOR DE GENERATED SURGICAL AORTIC BIOPROSTHESES: A 3-CENTER COMPARISON OF HEMODYNAMIC AND 1-YEAR OUTCOME. J AM HEART ASSOC. 2020 JUL 21;9(14):E013973. PMID: (B)(6). DOI: 10.1161/JAHA.119.013973. EPUB 2020 JUL 9 EARLIEST DATE OF PUBLISH USED FOR DATE OF EVENT AND DATE OF DEATH. MEDTRONIC PRODUCTS REFERENCED: COREVALVE, EVOLUT R (PMA# (B)(4), PRODUCT CODE: NPT), MOSAIC (PMA# (B)(4), PRODUCT CODE: DYE). 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 · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE COMPARING TRANSCATHETER VERSUS SURGICAL VALVE-IN-VALVE (VIV) AORTIC VALVE REPLACEMENT IN THE SETTING OF DEGENERATED SURGICAL BIOPROSTHESES. ALL DATA WERE RETROSPECTIVELY COLLECTED FROM MULTIPLE CENTERS BETWEEN NOVEMBER 4, 2009 AND MAY 10, 2018. THE STUDY POPULATION INCLUDED 99 PATIENTS (PREDOMINANTLY FEMALE, MEAN AGE 80 YEARS), 18 OF WHICH WERE PREVIOUSLY IMPLANTED WITH MEDTRONIC MOSAIC BIOPROSTHETIC VALVES (UNIQUE DEVICE IDENTIFIER NUMBERS NOT PROVIDED). OF THE STUDY POPULATION, 19 PATIENTS UNDERWENT EITHER TRANSCATHETER OR SURGICAL VALVE-IN-VALVE IMPLANTATION USING MEDTRONIC COREVALVE BIOPROSTHETIC VALVES AND SIX WERE IMPLANTED WITH MEDTRONIC EVOLUT R BIOPROSTHETIC VALVES (UNIQUE DEVICE IDENTIFIER NUMBERS NOT PROVIDED). AMONG ALL PATIENTS, ONE DEATH OCCURRED DUE TO A VENTRICULAR SEPTAL DEFECT CAUSED DURING THE PROCEDURE THAT COULD NOT BE CLOSED. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT MAY HAVE BEEN ASSOCIATED WITH THE DEATH. FOUR OTHER DEATHS WERE NOTED BE NON-VALVE-RELATED OR FROM AN UNKNOWN CAUSE. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT WAS NOT DIRECTLY ASSOCIATED WITH THOSE DEATHS. AMONG ALL MEDTRONIC MOSAIC PATIENTS, ADVERSE EVENTS INCLUDED: DEGENERATED VALVES LEADING TO SEVERE AORTIC STENOSIS AND/OR AORTIC REGURGITATION. THESE CONDITIONS REQUIRED TRANSCATHETER OR SURGICAL VALVE-IN-VALVE REPLACEMENTS. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT WAS DIRECTLY ASSOCIATED WITH THE ADVERSE EVENTS. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: PARAVALVULAR LEAK (PVL), ATRIAL FIBRILLATION AND HIGH-DEGREE AV BLOCK NECESSITATING PERMANENT PACEMAKER IMPLANTATION, CEREBROVASCULAR ACCIDENT (CVA) AND MAJOR BLEEDING. 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
    1011105 MEDTRONIC TRANSCATHETER VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION MDT-TRANS VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death| L| R