BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE-TEX CARDIOVASCULAR PATCH

    MDR report key: 3203695 · Received June 24, 2013

    Report

    Report Number
    3007284313-2013-00038
    Event Type
    Injury
    Date Received
    June 24, 2013
    Date of Event
    February 21, 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
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE LOT NUMBER IS NOT AVAILABLE; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS CANNOT BE PERFORMED. LITERATURE CITATION: YALCIN Y, ET.AL. TRANSCATHETER DEVICE CLOSURE OF A RESIDUAL POSTMYOCARDIAL INFARCTION VENTRICULAR SEPTAL DEFECT. TURKISH SOCIETY OF CARDIOLOGY 2011;39(6):491-494.

    Description of Event or Problem · 1

    THIS INFORMATION WAS RECEIVED THROUGH LITERATURE ARTICLE "TRANSCATHETER DEVICE CLOSURE OF A RESIDUAL POSTMYOCARDIAL INFARCTION VENTRICULAR SEPTAL DEFECT" PUBLISHED IN TURKISH SOCIETY OF CARDIOLOGY, FEBRUARY 21, 2011. THE ARTICLE REPORTS A PT SUFFERED AN ACUTE VENTRICULAR SEPTAL RUPTURE FOLLOWING MYOCARDIAL INFARCTION. THE PT UNDERWENT SURGICAL VENTRICULAR SEPTAL DEFECT (VSD) CLOSURE WITH A "GORE-TEX PATCH". INTRAOPERATIVE IMAGING SHOWED NO RESIDUAL SHUNT; HOWEVER, THE PT'S CONDITION REMAINED LABILE, AND TWO DAYS POST-PROCEDURE, IMAGING CONFIRMED A RESIDUAL SHUNT. THE PT'S CONDITION DETERIORATED OVER TIME AND ECHOCARDIOGRAPHIC IMAGING SHOWED ENLARGEMENT OF THE RESIDUAL DEFECT. TWENTY-ONE DAYS POST-PROCEDURE, THE PT UNDERWENT TRANSCATHETER VSD CLOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285378 GORE-TEX CARDIOVASCULAR PATCH DXZ / PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE DXZ W. L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other