BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVALUS AORTIC TISSUE VALVE

    MDR report key: 22579930 · Received July 23, 2025

    Report

    Report Number
    2025587-2025-05236
    Event Type
    Injury
    Date Received
    July 23, 2025
    Date of Event
    September 26, 2024
    Report Date
    July 23, 2025
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P170006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID: 40025, (UNKNOWN SERIAL/LOT); PRODUCT TYPE: 0195-HEART VALVES; CITATION: AAKASH ANGIREKULA., ET AL.. SUCCESSFUL REDO SURGICAL REPLACEMENT OF A FLAIL BIOPROSTHETIC AORTIC VALVE: A CASE REPORT. AM ERICAN JOURNAL OF CASE REPORTS 25: E945043 2024. 10.12659/AJCR.945043 EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. WITHOUT RETURN OF THE PRODUCT NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATIONS. 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 5 DAYS POST IMPLANT OF THIS MEDTRONIC 27MM AVALUS BIOPROSTHETIC VALVE, THE PATIENT DEVELOPED SYMPTOMATIC JUNCTIONAL BRADYCAR­DIA AND INTERMITTENT COMPLETE HEART BLOCK, NECESSITATING EX­TERNAL PACING. IT WAS REPORTED THAT A PERMANENT DUAL-CHAMBER PACEMAKER WAS IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25655 AVALUS AORTIC TISSUE VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION 40027

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Hospitalization| L| R