BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANCOCK II MITRAL BIOPROSTHETIC HEART VALVE

    MDR report key: 7908006 · Received September 25, 2018

    Report

    Report Number
    2025587-2018-02529
    Event Type
    Injury
    Date Received
    September 25, 2018
    Date of Event
    May 1, 2018
    Report Date
    September 25, 2018
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P980043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: DO-YOON KANG TRANSSEPTAL TRANSCATHETER MITRAL VALVE-IN-VALVE REPLACEMENT FOR A FAILED BIOPROSTHETIC MITRAL VALVE KOREAN CIRC J. 2018 MAY; 48(5): 438¿441. PUBLISHED ONLINE 2018 MAR 7. DOI: 10.4070/KCJ.2017.0364 PMCID: PMC5940651 PMID: 29671289 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.   WITHOUT THE 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 FEMALE PATIENT WITH ATRIAL FIBRILLATION, STROKE, AND RESTRICTIVE LUNG DISEASE WHO UNDERWENT IMPLANT OF A 27 MM MEDTRONIC HANCOCK II BIOPROSTHESIS DUE TO SEVERE RHEUMATIC MITRAL STENOSIS. NO SERIAL NUMBERS WERE PROVIDED. ELEVEN YEARS POST-IMPLANT, THE VALVE WAS REPLACED IN A VALVE-IN-VALVE PROCEDURE WITH A NON-MEDTRONIC VALVE DUE TO SEVERE MITRAL REGURGITATION (MR), PULMONARY HYPERTENSION AND PROLAPSE OF POSTERIOR LEAFLET OF THE BIOPROSTHETIC MITRAL VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746097 HANCOCK II MITRAL BIOPROSTHETIC HEART VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION T510

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention