BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2010792 · Received March 2, 2011

    Report

    Report Number
    2953200-2011-00582
    Event Type
    Injury
    Date Received
    March 2, 2011
    Date of Event
    January 31, 2011
    Report Date
    January 31, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS AND CONCLUSIONS: SEVERE ANGULATION OF THE RIGHT EXTERNAL ILIAC. EVAL SUMMARY: THE DISTAL SECTION OF THE GRAFT COVER WITH TAPER TIP AND UN-DEPLOYED STENT GRAFT WAS RETURNED COMPLETELY DETACHED AT THE STENT STOP. THERE WAS SEVERE TWISTING AT THE BREAKAGE POINT. THE GUIDEWIRE WAS NOT THE FULL LENGTH AND APPEARED TO HAVE BEEN CUT OFF DURING REMOVAL. THE GUIDEWIRE WAS NOT BROKEN OR DAMAGED WHERE THE GRAFT COVER DETACHED. THERE WERE KINKS ON THE GRAFT COVER BETWEEN THE FIRST 3 RINGS. THE DETACHED DISTAL SECTION WAS FREE OF ANY TWISTING PATTERNS. THERE WAS TWISTING (CANDYCANE) PATTERN ON THE GRAFT COVER SECTION THAT WAS STILL ATTACHED TO THE DELIVERY SYSTEM AND EXTENDED FOR A LENGTH OF 12CM. TWISTING ORIGINATED AT THE GRAFT COVER JUNCTION/TRANSITION BOND. THE TWISTING PATTERN BELOW THE STENT STOP MAY INDICATE THAT THE DISTAL SECTION WAS MOST LIKELY HELD STATIONARY DUE TO VESSEL MORPHOLOGY AND WAS NOT RESPONDING TO THE TORQUING APPLIED BY THE USER. THE CONTINUED TORQUING OF THE DEVICE AND THE USE OF FORCE WHILE THE DISTAL SECTION WAS STATIONARY RESULTED IN THE DETACHMENT OF THE DISTAL SECTION AT THE STENT STOP.

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 64 X 58 MM ABDOMINAL AORTIC ANEURYSM IN A CORPULENT PATIENT APPROXIMATELY 1 MONTH AGO. VESSEL MORPHOLOGY INCLUDED 10 MM OF NON CIRCUMFERENTIAL THROMBUS AND 5 MM OF NON CIRCUMFERENTIAL CALCIFICATION IN A LONG INFRARENAL NECK WITH A 20 DEGREE ANGLE. THE PROXIMAL PART OF THE RIGHT COMMON ILIAC ARTERY WAS WIDE. THERE WAS A VERY ELONGATED PROXIMAL PART OF THE RIGHT EXTERNAL ILIAC ARTERY WITH AN ANGLE OF MORE THAN 180 DEGREES. IT WAS REPORTED THAT PLACEMENT OF THE BIFURCATED STENT GRAFT OVER THE LEFT SIDE WAS NOT PROBLEMATIC BUT THEN IT WAS VERY DIFFICULT TO CANNULATE THE CONTRALATERAL STUB LEG. A COMPETITOR'S GUIDE WIRE WAS INTRODUCED INTO THE RIGHT ILIAC LEG WITHOUT DILATING THE VESSELS. IT WAS NOT POSSIBLE TO INTRODUCE THE NOSE-CONE PAST THE ENTRANCE OF THE STUB LEG. THE PHYSICIAN TRIED WITH SOME FORCE AND SEVERAL MOVEMENTS (TWISTING, PULLING, PUSHING, ETC.) TO INTRODUCE THE SYSTEM, WITHOUT SUCCESS. HE DECIDED TO REMOVE THE DELIVERY SYSTEM WITH THE GUIDE WIRE STILL IN PLACE. THE DISTAL PART OF THE DELIVERY SYSTEM MOVED DOWNWARD WHILE THE PROXIMAL PART (NOSE-CONE, AND STENT GRAFT, WAS STILL IN THE TUBING) DID NOT MOVE. THE COMPLETE DELIVERY SYSTEM WAS SEPARATED JUST BELOW THE LEVEL OF THE STENT GRAFT. THIS PART OF THE SYSTEM WAS CAPTURED WITH A SNARE AND REMOVED. AGAIN THE STUB LEG WAS CANNULATED, USING A CROSS-OVER PROCEDURE. ANOTHER GUIDE WIRE WAS INTRODUCED INTO THE STUB LEG BUT IT WAS DIFFICULT TO STRETCH OUT THE VESSELS. A NEW DEVICE WAS INTRODUCED SUCCESSFULLY. CONTROL ANGIOGRAM SHOWED CORRECT PLACEMENT WITHOUT ENDOLEAKS. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE. REF MFR # 2953200-2011-00583.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT ABDOMINAL STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00813158

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention