BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1211761 · Received October 24, 2008

    Report

    Report Number
    2953161-2008-00325
    Event Type
    Injury
    Date Received
    October 24, 2008
    Date of Event
    June 20, 2008
    Report Date
    October 23, 2008
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. RESULTS - THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. MANUFACTURER EXPLANT EVALUATION PER DEVICE PXC14100-05272451 ADVISED THE FOLLOWING: GROSS INSPECTION OF THE DEVICE BY TRANSILLUMINATION WITH FIBER OPTIC LIGHTS REVEALED A NARROW ELONGATED HOLE IN THE CONTRALATERAL LIMB APPROXIMATELY 1 CM DISTAL TO THE JUNCTION WITH THE CONTRALATERAL GATE. THIS LOCATION CORRESPONDS TO THE SITE OF THE LEAK IDENTIFIED AND DOCUMENTED BY THE PHYSICIAN. AFTER ENZYMATIC DIGESTION TO REMOVE ANY REMAINING BIOLOGICAL MATERIAL, THE DEVICE WAS EXAMINED FOR PHYSICAL DISRUPTIONS WITH THE AID OF A STEREOMICROSCOPE. TWO NARROW ELONGATED HOLES WERE OBSERVED AT THE PREVIOUSLY IDENTIFIED SITE ON THE CONTRALATERAL LIMB. THE ORIENTATION OF THE TWO HOLES WAS IDENTICAL, AND BOTH ALIGNED ALONG A DIAGONAL ANGLE ACROSS THE LIMB. CLOSER INSPECTION OF THE HOLES BY SCANNING ELECTRON MICROSCOPY (SEM) REVEALED SHARPLY DEFINED GRAFT EDGES WITH NO EVIDENCE OF FRICTIONAL WEAR. THE FEATURES OF THE HOLES WERE CONSISTENT WITH SLASHING DAMAGE BY A SHARP INSTRUMENT. IN ADDITION, THE ALIGNMENT, RELATIVE PROXIMITY, AND IDENTICAL ORIENTATION OF THE HOLES SUGGEST THEY MAY HAVE BEEN FORMED SIMULTANEOUSLY, POSSIBLY AS AN INADVERTENT STROKE OF A SHARP SURGICAL INSTRUMENT ACROSS THE DEVICE DURING THE CONVERSION SURGERY. NO OTHER DISRUPTIONS WERE IDENTIFIED. PLEASE NOTE THAT THIS EVENT HAS ALREADY BEEN REPORTED UNDER MEDWATCH 2017233-2008-00391. HOWEVER, UPON REVIEW OF THE FILE, IT WAS NOTED THAT THIS DEVICE WAS REPORTED UNDER THE INCORRECT MANUFACTURER REPORT NUMBER. THEREFORE, THIS MEDWATCH WAS CREATED AND SUBMITTED.

    Description of Event or Problem · 1

    IN 2008, THIS PATIENT WAS IMPLANTED EMERGENTLY WITH A GORE EXCLUDER AAA ENDOPROSTHESES TO REPAIR A RUPTURED INFRARENAL ABDOMINAL AORTIC ANEURYSM. THE ANEURYSM WAS SEALED, NO ENDOLEAK WAS IDENTIFIED, AND THE PATIENT TOLERATED THE PROCEDURE. TWO MONTH LATER, THIS PATIENT PRESENTED AND WAS PRE-OPERATIVELY DIAGNOSED WITH A RUPTURED ANEURYSM SAC, HEMORRHAGE, AND A RETROPERITONEAL HEMATOMA. THE PATIENT WAS CONVERTED TO OPEN SURGICAL REPAIR. INTRA-OPERATIVELY, THE PATIENT WAS DISCOVERED TO HAVE AN INFECTED RUPTURED ABDOMINAL AORTIC ANEURYSM, THE GORE EXCLUDER AAA ENDOPROSTHESIS WAS REPORTED TO BE INFECTED, AND A TYPE III ENDOLEAK WAS IDENTIFIED. DURING THE CONVERSION, THE GORE EXCLUDER AAA ENDOPROSTHESIS WAS EXPLANTED AND THE PATIENT WAS REPAIRED SURGICALLY. THE PATIENT WAS TRANSPORTED TO THE RECOVERY ROOM IN SERIOUS BUT STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA ENDOPROSTHESIS NONE MIH W. L. GORE & ASSOCIATES, INC. WLG325 05695667

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention