BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 3034615 · Received March 27, 2013

    Report

    Report Number
    2017233-2013-00175
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    September 10, 2010
    Report Date
    February 28, 2013
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REFER TO THE JOURNAL OF VASCULAR SURGERY "LATE GORE EXCLUDER ENDOPROSTHESIS FABRIC TEAR LEADING TO ABDOMINAL AORTIC ANEURYSM RUPTURE 5 YEARS AFTER INITIAL IMPLANT" JANUARY 2013 (VOL. 57, NUMBER 1: 221-224).

    Description of Event or Problem · 1

    AS REPORTED IN THE JOURNAL OF VASCULAR SURGERY "LATE GORE EXCLUDER ENDOPROSTHESIS FABRIC TEAR LEADING TO ABDOMINAL AORTIC ANEURYSM RUPTURE 5 YEARS AFTER INITIAL IMPLANT" JANUARY 2013 (VOL. 57, NUMBER 1: 221-224), THIS PATIENT UNDERWENT TREATMENT OF A 6.7 CM ABDOMINAL AORTIC ANEURYSM WITH FOUR GORE EXCLUDER AAA ENDOPROSTHESES ON FEBRUARY 4, 2005. ON SEPTEMBER 10, 2010, THE PATIENT PRESENTED WITH LOWER ABDOMINAL AND BACK PAIN, AND A CT SCAN SHOWED A RETROPERITONEAL HEMATOMA THAT REPORTEDLY COULD BE ASSOCIATED WITH AN ANEURYSM RUPTURE DUE TO A TYPE III ENDOLEAK. AFTER RESUSCITATION AND SUBSTITUTION OF BLOOD PRODUCTS, THE PATIENT WAS TAKEN TO SURGERY. INTRA-OPERATIVE AORTOGRAPHY REPORTEDLY SHOWED SIGNIFICANT CONTRAST EXTRAVASATION INTO THE ANEURISMAL SAC AT THE SITE OF THE RUPTURE. IT WAS REPORTED THE EXACT LOCATION OF THE TEAR WAS DIFFICULT TO IDENTIFY, BUT THE FABRIC TEAR WAS MOST LIKELY LOCATED AT THE LEVEL OF THE FLOW DIVIDER AT THE SIDE OF THE RIGHT LIMB. PROXIMAL ANGIOPLASTY WAS PERFORMED, AND THEN THREE ADDITIONAL DEVICES WERE IMPLANTED. REPEAT ANGIOGRAPHY SHOWED NO EVIDENCE OF ENDOLEAK WITH GOOD FLOW INTO THE RENAL ARTERIES. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127343 GORE EXCLUDER AAA ENDOPROSTHESIS MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 03089223

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R WARFARIN