BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THV 1000-29 3F AORTIC BIO 29MM

    MDR report key: 19472326 · Received June 5, 2024

    Report

    Report Number
    2025587-2024-03295
    Event Type
    Injury
    Date Received
    June 5, 2024
    Date of Event
    May 21, 2024
    Report Date
    June 5, 2024
    Manufacturer
    MEDTRONIC 3F THERAPEUTICS, INC.
    Product Code
    LWR
    UDI-DI
    00613994868268
    PMA / PMN Number
    P060025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION THAT 12 YEARS AND 10 MONTHS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED AS SEVERE AORTIC REGURGITATION (AR). NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    806630 THV 1000-29 3F AORTIC BIO 29MM HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC 3F THERAPEUTICS, INC. 1000-29 00613994868268

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Life Threatening