BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 13664631 · Received March 3, 2022

    Report

    Report Number
    2025587-2022-00585
    Event Type
    Death
    Date Received
    March 3, 2022
    Date of Event
    January 20, 2022
    Report Date
    March 3, 2022
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: MEDRANDA ET AL. IMPACT OF LEFT VENTRICULAR OUTFLOW TRACT CALCIUM ON HEMODYNAMICS AND OUTCOMES IN PATIENTS AFTER TRANSCATHETER AORTIC VALVE IMPLANTATION WITH A CONTEMPORARY SELF-EXPANDING VALVE. AM J CARDIOL. 2022 JAN 20;S0002-9149(21)01245-5. DOI: 10.1016/J.AMJCARD.2021.12.019. EARLIEST DATE OF PUBLISH USED FOR DATE OF EVENT AND DATE OF DEATH. MEDTRONIC PRODUCTS REFERENCED: EVOLUT PRO, 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. 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 IMPACT OF LEFT VENTRICULAR OUTFLOW TRACT (LVOT) CALCIUM ON HEMODYNAMICS AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). ALL DATA WERE COLLECTED BETWEEN JANUARY 2018 THROUGH JUNE 2021 FROM A MULTI-CENTER DATA REGISTRY IN WHICH MEDTRONIC COLLABORATED WITH BUT WAS NOT THE SPONSOR OF. THE STUDY POPULATION INCLUDED 277 PATIENTS (PREDOMINANTLY FEMALE, MEAN AGE 81.5 YEARS). ALL PATIENTS WERE IMPLANTED WITH A MEDTRONIC EVOLUT PRO OR PRO+ BIOPROSTHETIC VALVE (UNIQUE DEVICE IDENTIFIER NUMBERS NOT PROVIDED). AMONG ALL PATIENTS, ONE IN-HOSPITAL DEATH OCCURRED. AN EXTREME-RISK (B)(6) YEAR-OLD FEMALE WITH SEVERE LVOT CALCIUM UNDERWENT TAVR USING A 29-MM EVOLUT PRO. THE IMPLANT PROCEDURE WAS COMPLICATED BY STENT FRAME INFOLDING. DILATATION OF THE NATIVE VALVE WITH A NON-MEDTRONIC BALLOON CAUSED AN ACUTE AORTIC ROOT RUPTURE. GIVEN THE PATIENT¿S ADVANCED AGE AND EXTREME RISK, SURGICAL REPAIR WAS NOT ATTEMPTED, AND THE PATIENT SUBSEQUENTLY DIED IN THE CATHETERIZATION LABORATORY. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT WAS ASSOCIATED WITH THE DEATH. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: ACUTE ANNULAR RUPTURE, MODERATE PARAVALVULAR LEAK (PVL), CARDIAC TAMPONADE REQUIRING PE RICARDIOCENTESIS AS INTERVENTION, STROKE, AND ARRHYTHMIA REQUIRING PERMANENT PACEMAKER IMPLANT. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT MAY HAVE BEEN ASSOCIATED WITH THE ADVERSE EVENT(S). NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1980332 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 Required Intervention| D| L