BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTEGRA

    MDR report key: 8180511 · Received December 19, 2018

    Report

    Report Number
    2025587-2018-03484
    Event Type
    Injury
    Date Received
    December 19, 2018
    Date of Event
    November 30, 2018
    Report Date
    January 3, 2019
    Manufacturer
    HEART VALVES SANTA ANA
    Product Code
    MWH
    PMA / PMN Number
    H020003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CORRECTION TO PMA / 510(K) # . IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CONDUIT WAS REPLACED DUE TO PATIENT OUTGROWTH. THE CONDUIT EXHIBITED MODERATE TO SEVERE STENOSIS AND MILD INSUFFICIENCY. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT 11 YEARS AND 25 DAYS POST IMPLANT OF THIS 18MM PULMONARY VALVED CONDUIT IMPLANTED IN A PEDIATRIC PATIENT, A 18MM TRANSCATHETER PULMONARY VALVE (TPV) WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1021025 CONTEGRA CONDUIT,VALVED,PULMONIC MWH HEART VALVES SANTA ANA 200SH18

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention