BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C3 EXCLUDER

    MDR report key: 2220473 · Received August 10, 2011

    Report

    Report Number
    2220473
    Event Type
    Malfunction
    Date Received
    August 10, 2011
    Date of Event
    July 8, 2011
    Report Date
    August 10, 2011
    Manufacturer
    GORE
    Product Code
    MIH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AFTER CONFIRMING THE GRAFT BEING APPROPRIATELY POSITIONED, AN ATTEMPT WAS MADE TO DEPLOY THE GRAFT. THE LIMB PORTION DID NOT DEPLOY. THE DELIVERY CATHETER COULD INITIALLY NOT BE REMOVED UNTIL THE SURGEON PASSED A 12 X 2 CM BALLOON THROUGH AND INFLATED WITHIN THE MAIN BODY OF THE PROSTHESIS. HE THEN PULLED ON THE DELIVERY DEVICE FIRMLY AND IT WAS REMOVED. IT WAS FOUND THAT FLOW TO THE LIMB OF THE GRAFT WAS COMPROMISED. A 23 X 2 CM BALLOON WAS THEN PASSED AS TO EXPAND THE LIMB OF THE GRAFT WHERE IT APPEARED TO BE STENOSED. THE BALLOON DID NOT RELIEVE THIS NARROWING. IN FACT, THE BALLOON RUPTURED AND THEN COULD NOT BE REMOVED UNTIL THE SURGEON APPLIED FIRM TRACTION ON THE BALLOON AND REMOVED IT. WHEN INSPECTED, THE DISTAL PORTION OF THE BALLOON REMAINED ON THE WIRE. BECAUSE FLOW TO THE EXTREMITY WAS COMPROMISED, THE SURGEON DECIDED TO PERFORM AN OPEN PROCEDURE, A LEFT TO RIGHT FEMORAL-FEMORAL BYPASS GRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C3 EXCLUDER SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM MIH GORE * *

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR