BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE-TEX CARDIOVASCULAR PATCH

    MDR report key: 2911114 · Received January 4, 2013

    Report

    Report Number
    3003910212-2013-00002
    Event Type
    Injury
    Date Received
    January 4, 2013
    Date of Event
    February 1, 2012
    Report Date
    December 11, 2012
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    FTL
    PMA / PMN Number
    K811841
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE COULD NOT BE CONDUCTED BECAUSE THE LOT # REMAINS UNKNOWN. THE DEVICE WAS DISCARDED, SO NO ENGINEERING INVESTIGATION COULD BE PERFORMED.

    Description of Event or Problem · 1

    IN AN ARTICLE TITLED, "HUGE RUPTURED AND INFECTED PSEUDOANEURYSM OF THE ASCENDING AORTA AND AORTIC ARCH WITH EROSION OF STERNUM AFTER PREVIOUS CARDIAC SURGERY", IT STATES A PATIENT UNDERWENT AORTIC VALVE REPLACEMENT AND CORONARY BYPASS GRAFTING IN THE (B)(6) IN 2007. IN 2011 THE PATIENT BEGAN HAVING REPEATED EPISODES OF UNSPECIFIC INFECTIONS. A COMPUTED TOMOGRAPHIC (CT) SCAN SHOWED A LARGE PSEUDOANEURYSM OF THE DISTAL ASCENDING AORTA. THE SITE OF THE AORTIC RUPTURE WAS CLOSED WITH A GORE-TEX PATCH AND A (B)(6) INFECTION WAS TREATED. TWO MONTHS LATER A SMALL CUTANEOUS LESION ON THE CRANIAL PART OF THE STERNOTOMY STARTED BLEEDING. CT SCAN DEMONSTRATED RECURRENCE OF A FALSE ANEURYSM WITH EROSION OF THE STERNUM AND A LARGE SUBCUTANEOUS HEMATOMA CAUSED BY THE FISTULA. THE PATIENT UNDERWENT A PROCEDURE TO REMOVE AND DEBRIDE THE TISSUE SURROUNDING THE INFECTED MATERIAL AND RECONSTRUCT THE ASCENDING AORTA, THE AORTIC ARCH, AND THE SUPRA-AORTIC VESSELS WITH BIOLOGIC MATERIAL. THE PREVIOUSLY SUTURED GORE-TEX PATCH WAS SAID TO BE FLOATING FREE IN THE UPPER MEDIASTINUM. FOLLOWING THE PROCEDURE, THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT. SEVEN DAYS LATER SHE HAD A PROCEDURE TO EVACUATE A MEDIASTINAL HEMATOMA. NEUROLOGICAL RECOVERY WAS UNEVENTFUL AND SHE WAS DISCHARGED FROM THE HOSPITAL ON POST-OPERATIVE DAY 22.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5335 GORE-TEX CARDIOVASCULAR PATCH NONE FTL W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention