BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIFURCATED GORE-TEX STRETCH VASCULAR GRAFT

    MDR report key: 3093919 · Received April 25, 2013

    Report

    Report Number
    2017233-2013-00262
    Event Type
    Injury
    Date Received
    April 25, 2013
    Date of Event
    March 29, 2013
    Report Date
    March 29, 2013
    Manufacturer
    W.L. GORE & ASSOCIATES,INC
    Product Code
    DSY
    PMA / PMN Number
    K904282
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. A HISTOLOGY AND ENGINEERING EVALUATION IS CURRENTLY IN PROCESS.

    Description of Event or Problem · 1

    ON (B)(6) 2011, A THIN-WALLED BIFURCATED GORE-TEX STRETCH VASCULAR GRAFT WAS IMPLANTED TO REPAIR AN ABDOMINAL AORTIC ANEURYSM. THE PROXIMAL END OF THE BIFURCATED GRAFT WAS ANASTOMOSED END-TO-END WITH THE AORTA. BOTH LEGS OF THE BIFURCATED GRAFT WERE ANASTOMOSED TO BOTH ILIAC ARTERIES. THERE ALSO WAS A BYPASS GRAFT FROM THE TRUNK OF BIFURCATED GRAFT TO THE RIGHT INTERNAL ILIAC ARTERY. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2003, AN OPEN SURGERY WAS PERFORMED TO REMOVE THE SEROMA. THE ANEURYSM WALL WAS CUT OFF WRAPPING THE GRAFT AND THE SEROMA WAS REMOVED. THE BIFURCATED GRAFT WAS PARTIALLY REPLACED WITH A DACRON BIFURCATED GRAFT. THE EXPLANTED GRAFT WAS RETURNED TO GORE FOR EVALUATION. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178917 BIFURCATED GORE-TEX STRETCH VASCULAR GRAFT DSY/PROSTHESIS, VASCULAR GRAFT DSY W.L. GORE & ASSOCIATES,INC 7200034

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR