BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 14147554 · Received April 19, 2022

    Report

    Report Number
    2025587-2022-01017
    Event Type
    Death
    Date Received
    April 19, 2022
    Date of Event
    March 22, 2022
    Report Date
    April 19, 2022
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: RHEUDE T, ET AL. MULTICENTER COMPARISON OF LATEST-GENERATION BALLOON-EXPANDABLE VERSUS SELF-EXPANDING TRANSCATHETER HEART VALVES: ULTRA VERSUS EVOLUT. INT J CARDIOL. 2022 MAR 22;S0167-5273(22)00402-8. DOI: 10.1016/J.IJCARD.2022.03.043. EARLIEST DATE OF PUBLISH USED FOR DATE OF EVENT AND DATE OF DEATH. MEDTRONIC PRODUCTS REFERENCED: EVOLUT R (PMA# P130021, PRODUCT CODE NPT), EVOLUT PRO (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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION FROM A LITERATURE ARTICLE REGARDING A COMPARISON OF LATEST-GENERATION BALLOON-EXPANDABLE AND SELF-EXPANDING TRANSCATHETER HEART VALVES. ALL DATA WAS COLLECTED FROM FIVE CENTERS BETWEEN NOVEMBER 2014 AND DECEMBER 2020. OF THE 934 PATIENTS INCLUDED IN THE STUDY POPULATION, 467 (PREDOMINANTLY FEMALE, MEDIAN AGE 82 YEARS) WERE IMPLANTED WITH A MEDTRONIC EVOLUT R OR EVOLUT PRO VALVE. NO UNIQUE DEVICE IDENTIFIER NUMBERS WERE PROVIDED. AMONG ALL EVOLUT R AND EVOLUT PRO PATIENTS, THE ALL-CAUSE MORTALITY RATE WAS 1.9% AT 30-DAY FOLLOW-UP. OF THESE, ONE INTRA-PROCEDURAL DEATH OCCURRED. THE CIRCUMSTANCES OF THIS DEATH WERE NOT DISCLOSED. HOWEVER, CONSIDERING THE TIME FRAME OF THE DEATH, MEDTRONIC PRODUCT MAY HAVE BEEN A CONTRIBUTORY CAUSE. NO DETAILS WERE PROVIDED FOR THE OTHER DEATHS. AMONG ALL EVOLUT R AND EVOLUT PRO PATIENTS, PROCEDURAL AND IN-HOSPITAL ADVERSE EVENTS INCLUDED: MULTIPLE VALVES IMPLANTED; VALVE MAL POSITIONING; CONVERSION TO OPEN SURGERY; ANNULAR RUPTURE; NEED FOR PERMANENT PACEMAKER IMPLANTATION; MAJOR VASCULAR COMPLICATIONS; LIFE-THREATENING BLEEDINGS; ALL-STROKE; MODERATE TO SEVERE PARAVALVULAR LEAK; AND ELEVATED GRADIENTS (> 20 MMHG). NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1367433 MEDTRONIC TRANSCATHETER VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION MDT-TRANS VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female Death