BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVALUS AORTIC TISSUE VALVE

    MDR report key: 10184011 · Received June 23, 2020

    Report

    Report Number
    2025587-2020-01992
    Event Type
    Injury
    Date Received
    June 23, 2020
    Date of Event
    May 22, 2020
    Report Date
    June 23, 2020
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    UDI-DI
    00643169983199
    PMA / PMN Number
    P170006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 620BG29, SERIAL/LOT #: (B)(4), PMA #: K032810, UBD: 05-JUL-2022, UDI#: (B)(4). PRODUCT ID: 900SFC32, SERIAL/LOT #: (B)(4), PMA #: K093903, UBD: 11-JAN-2024, UDI#: (B)(4). PRODUCT ANALYSIS: THE DEVICES REMAINS IMPLANTED; THEREFORE, NO PRODUCT ANALYSIS CAN BE PERFORMED. CONCLUSION: WITHOUT THE RETURN OF THE PRODUCTS, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. CONDUCTION DISTURBANCES ARE KNOWN POTENTIAL ADVERSE EFFECTS ASSOCIATED WITH ANY CARDIAC OR THORACIC PROCEDURE AND CAN BE RESOLVED WITH MEDICAL TREATMENT OR THE IMPLANT OF A PERMANENT PACEMAKER. A CONDUCTION DISTURBANCE DOES NOT INDICATE A DEVICE MALFUNCTION OR POTENTIAL MANUFACTURING ISSUE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT 5 DAYS POST IMPLANT OF THIS 23MM BIOPROSTHETIC AORTIC VALVE, 12 DAYS POST IMPLANT OF THIS 29 MM MITRAL ANNULOPLASTY BAND, AND 12 DAYS POST IMPLANT OF THIS 32MM TRICUSPID ANNULOPLASTY RING, A PERMANENT PACEMAKER WAS IMPLANTED IN THE PATIENT. THE REASON FOR THE PERMANENT PACEMAKER IMPLANT WAS REPORTED AS COMPLETE HEART BLOCK. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647494 AVALUS AORTIC TISSUE VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION 40023 00643169983199

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention