BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THV 1000-29 3F AORTIC BIO 29MM

    MDR report key: 12673794 · Received October 21, 2021

    Report

    Report Number
    2025587-2021-03117
    Event Type
    Injury
    Date Received
    October 21, 2021
    Date of Event
    September 28, 2021
    Report Date
    October 21, 2021
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P060025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: THE DEVICE REMAINS IMPLANTED, THEREFORE NO PRODUCT ANALYSIS CAN BE PERFORMED. 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 11 YEARS AND 4 MONTHS POST IMPLANT OF THIS 29MM AORTIC BIOPROSTHETIC VALVE, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS REPORTED AS MODERATE REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1572171 THV 1000-29 3F AORTIC BIO 29MM HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION 1000-29

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R