BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIFURCATED GORE-TEX STRETCH VASCULAR GRAFT

    MDR report key: 2072657 · Received April 21, 2011

    Report

    Report Number
    2017233-2011-00207
    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, A PT UNDERWENT OPEN REPAIR OF A 5CM AAA WITH A 16 X 8MM BIFURCATED GORE-TEX STRETCH VASCULAR GRAFT, WITH RE-IMPLANTATION OF THE LEFT RENAL ARTERY. FIVE YEARS LATER HE RETURNED WITH SEVERE ABDOMINAL PAIN RADIATING THROUGH TO THE BACK AND THE SCROTUM. THIS HAD FOLLOWED MANEUVERS BY A CHIROPRACTOR FOR TREATMENT OF THE CHRONIC BACK PAIN. A LAPAROTOMY WAS PERFORMED THAT REVEALED A LARGE AMOUNT OF SEMISOLID, RUBBERY GELATINOUS MATERIAL AND A SMALL AMOUNT OF STRAW-COLORED FLUID. THE SAC WAS FULLY EVACUATED AND CLOSED WITH IMBRICATING SUTURES. THE PT WAS SYMPTOM FREE AT 1 MONTH F/U.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention