BEUDAMED
    FDA Adverse Event Death Summary report: N

    CONTEGRA

    MDR report key: 8430120 · Received March 18, 2019

    Report

    Report Number
    2025587-2019-00969
    Event Type
    Death
    Date Received
    March 18, 2019
    Date of Event
    January 14, 2019
    Report Date
    March 19, 2019
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    MWH
    PMA / PMN Number
    H020003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: FR995-23, SERIAL/LOT #: (B)(4), UBD: 01-MAY-2023, UDI #: (B)(4), PMA/510(K) #: P970031. CONCLUSION: WITHOUT THE RETURN OF THE PRODUCTS, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATIONS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT FIVE YEARS AND FOUR MONTHS POST IMPLANT OF THIS 16 MM PULMONARY VALVED CONDUIT, IMPLANTED IN A (B)(6) PEDIATRIC PATIENT, THE CONDUIT WAS EXPLANTED DUE TO BECOMING ANEURYSMAL AND WAS REPLACED WITH 23 MM VALVE. ONE DAY POST VALVE IMPLANT, THE PATIENT DIED. THE PHYSICIAN REPORTED THE CAUSE OF DEATH WAS CARDIAC ARREST AND THE VALVE DID NOT CAUSE OR CONTRIBUTED TO THE DEATH. THE PHYSICIAN REPORTED THAT MULTIPLE POST-OPERATIVE ECHOCARDIOGRAM IMAGES SHOWED NORMAL ANATOMY. IT IS UNKNOWN WHETHER AN AUTOPSY WAS PERFORMED. CONCURRENT PROCEDURES PERFORMED: ASCENDING AORTIC GRAFT, REPAIR OF PULMONARY ARTERY STENOSIS BY RECONSTRUCTION WITH A GORE-TEX PATCH AND REPAIR OF ATRIAL SEPTAL DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221863 CONTEGRA CONDUIT,VALVED,PULMONIC MWH MEDTRONIC HEART VALVES DIVISION 200H16

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Death| R