BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANCOCK II AORTIC BIOPROSTHETIC HEART VALVE

    MDR report key: 7027302 · Received November 14, 2017

    Report

    Report Number
    2025587-2017-02104
    Event Type
    Injury
    Date Received
    November 14, 2017
    Date of Event
    May 1, 2015
    Report Date
    November 14, 2017
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P980043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: FRERKER C. EXPANSION OF THE INDICATION OF TRANSCATHETER AORTIC VALVE IMPLANTATION--FEASIBILITY AND OUTCOME IN "OFF-LABEL" PATIENTS COMPARED WITH "ON-LABEL" PATIENTS. J INVASIVE CARDIOL. MAY 2015; 27(5):229-36. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. 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 OUTCOMES OF PERFORMING TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI). ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN 2008 AND 2012. THE STUDY POPULATION INCLUDED 591 PATIENTS (PREDOMINANTLY FEMALE; MEAN AGE (B)(6) YEARS), 9 OF WHICH WERE IMPLANTED WITH MEDTRONIC HANCOCK (SERIAL NUMBERS NOT PROVIDED). AMONG ALL PATIENTS ADVERSE EVENTS INCLUDED: NINE PATIENTS WITH A DEGENERATED HANCOCK AORTIC BIOPROSTHESIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    807500 HANCOCK II AORTIC BIOPROSTHETIC HEART VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION T505

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention