BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THV 1000-27 3F AORTIC BIO 27MM

    MDR report key: 8416451 · Received March 13, 2019

    Report

    Report Number
    2025587-2019-00911
    Event Type
    Injury
    Date Received
    March 13, 2019
    Date of Event
    March 6, 2019
    Report Date
    May 21, 2019
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    UDI-DI
    00613994961594
    PMA / PMN Number
    P060025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE AORTIC BIOPROSTHETIC VALVE WAS REPLACED VALVE-IN-VALVE DUE TO SEVERE INSUFFICIENCY. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT 6 YEARS AND 6 MONTHS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209290 THV 1000-27 3F AORTIC BIO 27MM HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION 1000-27 00613994961594

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention