BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THV 1000-27 3F AORTIC BIO 27MM

    MDR report key: 9318102 · Received November 13, 2019

    Report

    Report Number
    2025587-2019-03469
    Event Type
    Injury
    Date Received
    November 13, 2019
    Date of Event
    April 10, 2012
    Report Date
    November 13, 2019
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    UDI-DI
    00613994961594
    PMA / PMN Number
    P060025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: THE DEVICE REMAINS IMPLANTED; THEREFORE, NO PRODUCT ANALYSIS CAN BE PERFORMED. CONCLUSION: WITHOUT THE RETURN OF THE PRODUCT, 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 37 DAYS POST IMPLANT OF THIS 27MM BIOPROSTHETIC AORTIC VALVE, 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
    1113873 THV 1000-27 3F AORTIC BIO 27MM HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION 1000-27 00613994961594

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention