BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2033471 · Received March 23, 2011

    Report

    Report Number
    2953161-2011-00071
    Event Type
    Malfunction
    Date Received
    March 23, 2011
    Date of Event
    March 2, 2011
    Report Date
    March 22, 2011
    Manufacturer
    W. L. GORE & ASSOCIATES
    Product Code
    MIH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: 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. PER THE GORE EXCLUDER AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), THE GORE EXCLUDER AAA ENDOPROSTHESIS IS INTENDED TO EXCLUDE THE ANEURYSM FROM THE BLOOD CIRCULATION IN PATIENTS DIAGNOSED WITH INFRARENAL ABDOMINAL AORTIC ANEURYSM (AAA) DISEASE AND WHO HAVE APPROPRIATE ANATOMY AS DESCRIBED: ADEQUATE ILIAC/FEMORAL ACCESS. ADDITIONAL THE IFU STATES: DO NOT ADVANCE THE DEVICE OUTSIDE OF THE SHEATH. THE SHEATH WILL PROTECT THE DEVICE FROM CATHETER BREAKAGE OR PREMATURE DEPLOYMENT WHILE TRACKING IT INTO POSITION. DO NOT CONTINUE ADVANCING ANY PORTION OF THE DELIVERY SYSTEM IF RESISTANCE IS FELT DURING ADVANCEMENT OF THE GUIDEWIRE, SHEATH, OR CATHETER. STOP AND ASSESS THE CAUSE OF RESISTANCE. VESSEL OR CATHETER DAMAGE MAY OCCUR.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PATIENT WAS IMPLANTED WITH FIVE GORE EXCLUDER AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT'S ACCESS VESSELS WERE CONSIDERABLY TORTUOUS ON BOTH THE LEFT AND THE RIGHT SIDE. DUE TO THE TORTUOSITY, THE PHYSICIAN STRUGGLED TO ADVANCE THE INTRODUCER SHEATH AND THE SHEATH WAS ONLY ADVANCED HALF WAY TO THE TARGET POSITION. WHILE ADVANCING A CONTRALATERAL LEG COMPONENT IT BECAME STUCK. THE PHYSICIAN PUSHED AND PULLED THE DELIVERY CATHETER RAPIDLY AND THE DEVICE BEGAN TO DEPLOY JUST DISTAL TO A PREVIOUSLY IMPLANTED CONTRALATERAL LEG COMPONENT. THE DEVICE WAS FULLY DEPLOYED AT THE POSITION WHERE IT BECAME STUCK. WHILE REMOVING THE DELIVERY CATHETER, THE PHYSICIAN NOTICED THE TIP OF THE CATHETER WAS DETACHED. THE TIP REMAINED ON THE GUIDEWIRE AND A GOOSENECK CATHETER WAS USED TO HELP RETRIEVE THE DETACHED TIP. A FINAL CONTRALATERAL LEG COMPONENT WAS IMPLANTED TO BRIDGE THE TWO DEVICES AND TO ALLOW FOR PROPER OVERLAP. NO FURTHER COMPLICATIONS WERE REPORTED AND THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA ENDOPROSTHESIS MIH/SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES WLG425 8655974

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR