BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANCOCK II MITRAL BIOPROSTHETIC HEART VALVE

    MDR report key: 7245948 · Received February 6, 2018

    Report

    Report Number
    2025587-2018-00307
    Event Type
    Injury
    Date Received
    February 6, 2018
    Date of Event
    October 1, 2017
    Report Date
    February 6, 2018
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P980043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: MARCO R PROSTHETIC VALVE ENDOCARDITIS INVOLVING THE MITRACLIP DEVICE. J CARD SURG NOV;32(11):696-697; EPUB: 2017 OCT 1 10. 1111/JOCS.13225 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.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REGARDING PROSTHETIC VALVE ENDOCARDITIS INVOLVING THE MITRACLIP DEVICE. MEDTRONIC RECEIVED INFORMATION THAT A (B)(6) MALE PATIENT WITH A MEDICAL HISTORY OF A BENTALL PROCEDURE, MITRAL VALVE CLIPS AND COMPLETE HEART BLOCK (CHB) WAS IMPLANTED WITH A 29 MM HANCOCK II BIOPROSTHETIC VALVE IN THE MITRAL POSITION (SERIAL NUMBER NOT PROVIDED). ADVERSE EVENTS INCLUDED: RE-EXPLORATION FOR BLEEDING, LOW CARDIAC OUTPUT SYNDROME, GRADE III ATRIOVENTRICULAR(AV) BLOCK AND PERMANENT PACEMAKER IMPLANTATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87751 HANCOCK II MITRAL BIOPROSTHETIC HEART VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION T510

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention