BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE-TEX CARDIOVASCULAR PATCH

    MDR report key: 3204298 · Received June 25, 2013

    Report

    Report Number
    2017233-2013-00397
    Event Type
    Injury
    Date Received
    June 25, 2013
    Date of Event
    April 18, 2011
    Report Date
    June 7, 2013
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DXZ
    PMA / PMN Number
    K811841
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE LOT NUMBERS ARE NOT AVAILABLE; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS CANNOT BE PERFORMED. LITERATURE CITATION: RUDRA, H.S. ET AL, THE ARTERIAL SWITCH OPERATION: 25-YEAR EXPERIENCE WITH 258 PATIENTS, ANNALS OF THORACIC SURGERY 2011; 92:1742-6.

    Description of Event or Problem · 1

    THIS INFORMATION WAS RECEIVED THROUGH LITERATURE ARTICLE "THE ARTERIAL SWITCH OPERATION: 25 YEAR EXPERIENCE WITH 258 PATIENTS," PUBLISHED IN THE ANNALS OF THORACIC SURGERY, APRIL 2011. THIS ARTICLE CITES REINTERVENTION RATES OF PTS WHO UNDERWENT ARTERIAL SWITH OPERATION FOR TRANSPOSITION OF THE GREAT ARTERIES. THREE REINTERVENTIONS ARE NOTED FOR PTS WHO HAD NEOPULMONARY ARTER RECONSTRUCTION USING A "GORE-TEX PATCH."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288086 GORE-TEX CARDIOVASCULAR PATCH DXZ/PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE DXZ W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 Other