BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THV 1000-27 3F AORTIC BIO 27MM

    MDR report key: 8699733 · Received June 14, 2019

    Report

    Report Number
    2025587-2019-01937
    Event Type
    Injury
    Date Received
    June 14, 2019
    Date of Event
    June 10, 2019
    Report Date
    June 14, 2019
    Manufacturer
    MEDTRONIC HEART VALVE DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P060025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: NO PRODUCT WAS RETURNED. 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 9 YEARS AND 7 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
    492885 THV 1000-27 3F AORTIC BIO 27MM HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVE DIVISION 1000-27

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention