BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIFURCATED GORE-TEX STRETCHER VASCULAR GRAFT

    MDR report key: 2072659 · Received April 21, 2011

    Report

    Report Number
    2017233-2011-00206
    Event Type
    Injury
    Date Received
    April 21, 2011
    Report Date
    April 20, 2011
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DSY
    PMA / PMN Number
    K904282
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT INFO WAS OBTAINED FROM THE FOLLOWING ARTICLE: THOO CH, BOURKE BM, MAY J. SYMPTOMATIC SAC ENLARGEMENT AND RUPTURE DUE TO SEROMA AFTER OPEN ABDOMINAL AORTIC ANEURYSM REPAIR WITH POLYTETRAFLUOROETHYLENE GRAFT: IMPLICATIONS FOR ENDOVASCULAR REPAIR AND ENDOTENSION. J VASC SURG 2004;40:1089-94.

    Description of Event or Problem · 1

    AS STATED IN LITERATURE ARTICLE, PT UNDERWENT AN OPEN REPAIR OF A 4.3CM ABDOMINAL AORTIC ANEURYSM AND 5.3CM RIGHT COMMON ILIAC ANEURYSM WITH 14 X 7MM BIFURCATED GORE-TEX STRETCH VASCULAR GRAFT. FIVE YEARS LATER, THE PT PRESENTED WITH RIGHT ILIAC FOSSA PAIN. A SAC WAS OBSERVED SURROUNDING THE RIGHT LIMB OF THE GRAFT, WITH NO EVIDENCE OF ANASTOMOTIC OR OTHER LEAK. CONSERVATIVE TREATMENT WAS ADMINISTERED, AND THE PAIN RESOLVED. ONE YEAR LATER, THE PT PRESENTED WITH A RECURRENCE OF THE PAIN, AND OPEN EXPLORATION WAS PERFORMED. WHEN THE SAC WAS OPENED, A LARGE AMOUNT OF RUBBERY, GELATINOUS SEMISOLID MATERIAL AND A LITTLE STRAW-COLORED FLUID WAS RELEASED UNDER TENSION, AND EVACUATED. THERE WAS NO EVIDENCE OF AN ARTERIAL LEAK FROM THE ANASTOMOSES OR FROM THE GRAFT. THE DEAD SPACE AROUND THE LIMB WAS REDUCED WITH IMBRICATING SUTURES. THE PT HAS REMAINED ASYMPTOMATIC FOR TWO YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIFURCATED GORE-TEX STRETCHER VASCULAR GRAFT DSY / PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER DSY W.L. GORE & ASSOCIATES WLG302

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention