BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THV 1000-27 3F AORTIC BIO 27MM

    MDR report key: 22306227 · Received June 23, 2025

    Report

    Report Number
    2025587-2025-04388
    Event Type
    Injury
    Date Received
    June 23, 2025
    Date of Event
    June 9, 2025
    Report Date
    June 23, 2025
    Manufacturer
    MEDTRONIC 3F THERAPEUTICS, INC.
    Product Code
    LWR
    UDI-DI
    00613994868251
    PMA / PMN Number
    P060025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 10 YEARS AND 8 MONTHS POST IMPLANT OF THIS 27MM 3F AORTIC VALVE, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS REPORTED AS SEVERE AORTIC INSUFFICICENCY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786960 THV 1000-27 3F AORTIC BIO 27MM HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC 3F THERAPEUTICS, INC. 1000-27 00613994868251

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Life Threatening| R| H