BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIFURCATED GORE-TEX STRETCH VASCULAR GRAFT

    MDR report key: 2071838 · Received April 21, 2011

    Report

    Report Number
    2017233-2011-00208
    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 INFORMATION 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 POLYTETRAFLUROETHYLENE 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 PATIENT UNDERWENT REPAIR OF A 6CM AAA WITH A 14 X 7MM BIFURCATED GORE-TEX STRETCH VASCULAR GRAFT. FIVE YEARS LATER, THE PATIENT PRESENTED WITH SEVERE PAIN FROM THE RIGHT LOIN TO THE GROIN. A RETROPERITONEAL HEMATOMA WAS REVEALED. A LARGE AMOUNT OF SEMISOLID RUBBERY GELATINOUS MATERIAL AND A SMALL AMOUNT OF STRAW-COLORED FLUID UNDER TENSION WAS RELEASED FROM THE SAC. A LARGE POSTERIOR TEAR WAS PRESENT IN THE SAC. THERE WAS NO BLEEDING FROM THE AORTIC GRAFT OR FROM THE ANASTOMOSES. THE SAC WAS TREATED WITH IMBRICATING SUTURES. THE PATIENT WAS ASYMPTOMATIC AT 12-MONTH FOLLOW-UP WITH A NORMAL APPEARING CT SCAN AND NO EVIDENCE OF RECURRENT SAC ENLARGEMENT OR INFECTION.

    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 68 YR Required Intervention