BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT PRO TRANSCATHETER AORTIC VALVE

    MDR report key: 10532611 · Received September 14, 2020

    Report

    Report Number
    2025587-2020-02827
    Event Type
    Injury
    Date Received
    September 14, 2020
    Date of Event
    May 1, 2020
    Report Date
    September 14, 2020
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: AJMAL M., ET AL. TRANSCATHETER AORTIC VALVE REPLACEMENT IN CARDIOGENIC SHOCK WITH PERCUTANEOUS TANDEMHEART SUPPORT. CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, MAY 2020; 95:S173, IV-3. EARLIEST DATE OF PUBLISH USED FOR EVENT DATE. [MEDTRONIC PRODUCTS REFERENCED: 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 · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REGARDING A (B)(6)-YEAR-OLD MALE PATIENT WITH SEVERE AORTIC STENOSIS IN CARDIOGENIC SHOCK WHO UNDERWENT IMPLANT OF A 29-MM MEDTRONIC EVOLUT PRO BIOPROSTHETIC VALVE (NO SERIAL NUMBER WAS PROVIDED). DURING IMPLANTATION, THE PATIENT DEVELOPED COMPLETE HEART BLOCK, REQUIRING TEMPORARY TRANS-VENOUS PACING AND LATER PLACEMENT OF AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE PATIENT WAS LATER DISCHARGED FROM THE HOSPITAL IN STABLE CONDITION. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    992999 EVOLUT PRO TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION EVOLUTPRO-23

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Life Threatening| R