BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTEGRA

    MDR report key: 4232957 · Received November 6, 2014

    Report

    Report Number
    2025587-2014-00852
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    August 29, 2014
    Report Date
    November 25, 2014
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    MWH
    PMA / PMN Number
    H020003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS PRODUCT MET ALL MANUFACTURING SPECIFICATIONS FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. REGURGITATION IS A KNOWN ADVERSE EVENT AND IS DOCUMENTED IN THE DEVICE RISK MANAGEMENT FILES. WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO MEDTRONIC; IT IS NOT KNOWN IF THE DEVICE WAS DISCARDED AFTER EXPLANT. (B)(4).

    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 THIS PULMONARY BIOPROSTHETIC VALVED CONDUIT (PVC) WAS REPLACED FOUR YEARS AFTER IMPLANT DUE TO SEVERE PULMONARY INSUFFICIENCY. THE DEVICE WAS REPLACED WITH ANOTHER MANUFACTURER¿S PULMONARY HOMOGRAFT, WHICH WAS REPLACED FOUR DAYS LATER WITH A 16MM VERSION OF THIS MEDTRONIC DEVICE. NO SUBSEQUENT ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715219 CONTEGRA CONDUIT,VALVED,PULMONIC MWH MEDTRONIC HEART VALVES DIVISION 200H12

    Patients

    Seq Age Sex Outcome Treatment
    1 00045 MO Required Intervention