BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THV 1000-23 3F AORTIC BIO 23MM

    MDR report key: 8016911 · Received October 29, 2018

    Report

    Report Number
    3008592544-2018-00048
    Event Type
    Injury
    Date Received
    October 29, 2018
    Date of Event
    October 23, 2018
    Report Date
    October 29, 2018
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    UDI-DI
    00613994868237
    PMA / PMN Number
    P060025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT 7 YEARS AND 5 MONTHS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE DUE TO SEVERE INSUFFICIENCY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    856839 THV 1000-23 3F AORTIC BIO 23MM HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION 1000-23 00613994868237

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention