BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THV 1000-29 3F AORTIC BIO 29MM

    MDR report key: 23725716 · Received December 5, 2025

    Report

    Report Number
    2025587-2025-06005
    Event Type
    Malfunction
    Date Received
    December 5, 2025
    Date of Event
    November 26, 2025
    Report Date
    December 5, 2025
    Manufacturer
    MEDTRONIC 3F THERAPEUTICS, INC.
    Product Code
    LWR
    UDI-DI
    00613994868268
    PMA / PMN Number
    P060025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 14 YEARS AND 4 MONTHS POST IMPLANT OF THIS 29MM 3F AORTIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. SITE REPORTS VALVE WAS SEWN INSIDE 30MM GELWEAVE VALSALVA DACRON GRAFT WITH LIMA TOLAD. EVIDENCE OF ANTERIOR CALCIFICATION IN THE RFA AND PLAQUE/THROMBUS SEEN IN ABDOMINAL AORTA AND RCI. THE REASON FOR EVALUATION WAS NOT REPORTED. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2866190 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 77 YR Male