BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANCOCK II AORTIC BIOPROSTHETIC HEART VALVE

    MDR report key: 7203611 · Received January 18, 2018

    Report

    Report Number
    2025587-2018-00203
    Event Type
    Injury
    Date Received
    January 18, 2018
    Date of Event
    March 27, 2017
    Report Date
    January 18, 2018
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P790007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: FAN J. A RARE CASE REPORT OF EARLY BIOPROSTHETIC VALVE THROMBOSIS PRESENTING WITH ACUTE HEART FAILURE SALVAGED BY THROMBECTOMY. J CARDIOTHORAC SURG. (B)(6) 2017;12(1):19. DOI: 10.1186/S13019-017-0581-9. EARLIEST DATE OF PUBLISH USED FOR EVENT DATE. 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 (B)(6) MALE WITH CONGENITAL BICUSPID AORTIC VALVE HAD BEEN IMPLANTED WITH 21 MM HANCOCK II PORCINE VALVE. THE SERIAL NUMBER WAS NOT PROVIDED. AT 11-MONTHS POST-IMPLANT, THE PATIENT BECAME HEMODYNAMICALLY UNSTABLE DUE TO AORTIC VALVE STENOSIS SECONDARY TO THROMBUS FORMATION IN THE AORTIC VALVE. AN INCREASED MEAN TRANSVALVULAR GRADIENT OF 58 MMHG WITH A RESTRICTED VALVE OPENING WAS NOTED. A SURGICAL EXPLORATION WAS PERFORMED SHOWING THROMBUS ADHERED TO THE AORTIC SIDE WITH DIFFUSE VALVULAR THICKENING. A THROMBECTOMY WAS PERFORMED. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE PROBLEMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47595 HANCOCK II AORTIC BIOPROSTHETIC HEART VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION T505

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention