BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2230636 · Received August 12, 2011

    Report

    Report Number
    2953200-2011-01430
    Event Type
    Death
    Date Received
    August 12, 2011
    Date of Event
    July 17, 2011
    Report Date
    August 9, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS OF EVAL: (CONVERSION TO SURGICAL REPAIR), (LOST WIRE POSITION). CONCLUSION: (LOST WIRE POSITION).

    Description of Event or Problem · 1

    AN ENDURANT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A 5.4 CM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. THE AORTIC NECK WAS 2.1 CM LONG, 25 MM IN DIAMETER PROXIMALLY AND 29 MM DISTALLY, CALCIFIED, AND HAD MINIMAL ANGULATION OF 5 DEGREES. THE ILIAC ARTERIES WERE CALCIFIED WITH MINIMAL TO MODERATE TORTUOSITY. IT WAS REPORTED THAT THE WHEN THE BIFURCATED STENT GRAFT WAS DEPLOYED, THE SUPRARENAL STENTS WERE RELEASED FROM THE SLEEVE W/O ANY ENTANGLEMENT OF THE BARE SPRINGS. THE NOSE CONE WAS PUSHED UPWARDS ABOVE THE RENAL ARTERIES, AND THE SPINDLE WAS RECAPTURED. THE DELIVERY SYSTEM WAS THEN PULLED DOWNWARDS TO BRING THE NOSE CONE INTO THE STENT GRAFT, WHEN THE BASE OF THE SPINDLE/SLEEVE CAUGHT ON ONE OF THE SUPRARENAL STENTS. TROUBLESHOOTING ATTEMPTS WERE PERFORMED, INCLUDING PUSHING THE DELIVERY SYSTEM UPWARDS, ROTATING THE DEVICE COUNTER-CLOCKWISE AND CLOCKWISE, REOPENING THE SPINDLE, BALLOONING, AND FINALLY PULLING THE WIRE DOWN INTO THE NOSE CONE. THE NOSE CONE THEN CAUGHT ON ONE OF THE OTHER BARE SPRINGS, AND WHEN PULLING ON THE DELIVERY SYSTEM, THE STENT GRAFT WAS ALSO BEING PULLED DOWN. THE PHYSICIAN ELECTED TO SURGICALLY REMOVE THE STENT GRAFT AND DELIVERY SYSTEM VIA AN OPEN REPAIR IN WHICH A DACRON GRAFT WAS SEWN IN. NO ADD'L CLINICAL SEQUELAE WERE REPORTED, AND THE PT IS FINE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE USER FACILITY: IT WAS REPORTED THAT ON MAGNIFIED FLUOROSCOPY THE PHYSICIAN COULD SEE ONE OF THE BARBS DEFINITELY BENT IN THE NECK OF THE ANEURYSM. IT WAS UNKNOWN IF IT WAS BENT OUTSIDE OR INSIDE. A RELIANT BALLOON WAS USED TO STABILIZE THE GRAFT WHILE ATTEMPTING AGAIN TO PULL THE DELIVERY CATHETER OUT. THE CASE WAS MOVED TO OPEN PROCEDURE TO REMOVE THE DEVICE. VISUAL EXAMINATION REVEALED THAT ONE OF THE BARBS HAD INDEED BEEN CAUGHT BY THE DELIVERY CATHETER AND COMPLETELY TWISTED AROUND THE DELIVERY CATHETER, MAKING A LOOP COMPLETELY AROUND THE CATHETER. THE PHYSICIAN HAD TO CUT OFF THE END OF THE DELIVERY CATHETER, IN ORDER TO REMOVE THE DELIVERY CATHETER, AS IT STUCK OUT OF THE TOP OF THE GRAFT. THIS WAS DONE AFTER ACTUALLY DIVIDING THE BARB THAT WAS COMPLETELY BENT IN A CIRCLE AROUND THE DELIVERY CATHETER. ONCE THE DEVICE WAS FREED FROM THE CATHETER, THE CATHETER WAS PULLED OUT OF THE RIGHT GROIN. THE REMAINDER OF THE DEVICE ITSELF WAS REMOVED BY OPENING EACH ILIAC ARTERY AND PULLING THE ILIAC LIMBS OUT. AN 18 TUBE GRAFT WAS USED TO REPAIR THE ANEURYSM. IT WAS REPORTED THAT THE PATIENT EXPIRED THREE DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00882062

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Death| R