BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II

    MDR report key: 3253172 · Received July 29, 2013

    Report

    Report Number
    2953200-2013-01467
    Event Type
    Injury
    Date Received
    July 29, 2013
    Date of Event
    March 5, 2015
    Report Date
    April 8, 2015
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION METHOD: (FILM REVIEW). EVALUATION RESULTS AND CONCLUSION: (STENT GRAFT OCCLUSION). (SMALL CALCIFIED ILIAC ARTERIES).

    Description of Event or Problem · 1

    REVIEW OF PRE-IMPLANT CTA¿S REVEALED THAT THE PATIENT¿S PROXIMAL NECK DIAMETER WAS 21X22MM JUST BELOW THE LEVEL OF THE RENALS. THE NECK WAS MINIMALLY ANGULATED AND CONTAINED AREAS OF CALCIFICATION. THE MAX AAA DIAMETER MEASURED 4.8 AND THE SAC CONTAINED THROMBUS (2CM FLOW LUMEN). THE DISTAL AORTIC DIAMETER WAS 22M WITH AREAS OF CALCIFICATION. THE ILIACS WERE STRAIGHT BUT MODERATELY CALCIFIED. THE RIGHT COMMON ILIAC DIAMETER RANGED FROM 10 ¿ 16MM, AND THE LEFT COMMON ILIAC ARTERY DIAMETER WAS 11MM. REVIEW OF CTA¿S FROM 2 YEARS POST-IMPLANT CONFIRMED THAT 2 LIMBS HAD BEEN PLACED WITHIN THE BIFURCATE RAISING THE ¿FLOW DIVIDER¿ UP TO NEAR THE LEVEL OF THE RENALS. THE IPSI AND CONTRA LIMBS WERE CROSSED. BEGINNING JUST BELOW THE RENALS, THE LEFT ¿RAISED¿ EXTENSION AND IPSILATERAL LIMB WERE TOTALLY OCCLUDED. BLOOD FLOW RESUMED DISTALLY SEVERAL CM¿S ABOVE THE DISTAL END OF THE LEFT LIMB AND CONTINUED DISTALLY INTO THE LEFT FEMORAL ARTERY. A SMALL AMOUNT OF THROMBUS WAS ALSO SEEN BELOW THE FLOW DIVIDER WITHIN THE CONTRA/RIGHT LIMB. THE ID OF THE ¿RAISED¿ EXTENSION, WITHIN THE AORTIC BODY WAS COMPRESSED DOWN TO 9 X 13MM ID, AND WITHIN THE ¿TRUE¿ FLOW DIVIDER WAS 10MM ID. WITHIN THE DISTAL AORTA THE LEFT LIMB ID IS 9MM AND THE LEFT LIMB ID WITHIN THE PATENT DISTAL LEFT ILIAC WAS 9MM. THE CAUSE OF THE LEFT LIMB THROMBUS COULD NOT BE DETERMINED. IT IS POSSIBLE THAT THE LIMB COMPRESSION SEEN WITHIN THE AORTIC BODY DUE TO PLACEMENT WITHIN THE SMALL ANATOMY MAY HAVE CONTRIBUTED. THIS MAY ALSO BE A CONTINUATION OF THE PREVIOUS THROMBUS SEEN 5-MONTHS POST-IMPLANT THAT WAS REPAIRED, WHICH MAY ALSO HAVE BEEN CAUSED BY THE PATIENT¿S TIGHT ANATOMY. THIS MAY ALSO BE DUE TO A PATIENT CONDITION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD RETURNED WITH ANOTHER THROMBOSIS OF THE LEFT LIMB. IT WAS NOTED THAT THE PATIENT DID NOT HAVE LIMB THREATENING ISCHEMIA, BUT DID HAVE HIP AND BUTTOCKS CLAUDICATION WITH ACTIVITY. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY. IT WAS THEN REPORTED THAT A CT SCAN ALSO DISCOVERED THAT THE LIMB PROVIDING THE LEFT LEG RUN OFF WAS OCCLUDED. IT WAS NOTED THAT THERE WAS RECONSTITUTION WITH IN THE STENT GRAFT AT THE DISTAL EXTERNAL ILIAC LEVEL ON THE LEFT, NEAR THE ILIAC BIFURCATION, PRESUMABLY FROM RETROGRADE FLOW THROUGH THE LEFT INTERNAL ILIAC ARTERY. THE PATIENT UNDERWENT SURGERY FOR LEFT LEG ISCHEMIA SECONDARY TO RECURRENT LEFT GRAFT LIMB THROMBOSIS STATUS, POST ENDOVASCULAR REPAIR. A FEMORAL-FEMORAL BYPASS WAS PERFORMED. THE GRAFT WAS REPORTEDLY TRIMMED AND SPATULATED END-TO-SIDE AND ANASTOMOSIS WAS COMPLETED BY RUNNING A SUTURE. IT WAS ALSO NOTED THAT THE GRAFT WAS FLUSHED PRIOR TO THE COMPLETION OF ANASTOMOSIS. EXCELLENT DOPPLER FLOW SIGNALS WERE REPORTED AT THE COMPLETION OF SURGERY. THE PATIENT WAS REPORTEDLY MOVED FROM THE OPERATING ROOM TO RECOVERY IN SATISFACTORY STABLE CONDITION.

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 5CM DIAMETER ABDOMINAL AORTIC ANEURYSM. THE AORTIC NECK WAS 17 - 20 MM IN LENGTH, AND 20.3 MM TO 21 MM IN DIAMETER FROM PROXIMAL TO DISTAL. THERE WAS MILD NECK ANGULATION AND MODERATE CALCIFICATION. THE ILIAC ARTERIES WERE MILDLY CALCIFIED. THE AORTIC BIFURCATION WAS 20 MM IN DIAMETER. THE RIGHT ILIAC WAS 4 CM IN LENGTH, AND MEASURED 12, 16, 15, 12 MM IN DIAMETER FROM PROXIMAL TO DISTAL. THE LEFT ILIAC WAS 4 CM IN LENGTH, AND MEASURED 9, AND 11 MM IN DIAMETER FROM PROXIMAL TO DISTAL. NO COMPLICATIONS HAVE BEEN REPORTED SINCE THE TIME OF IMPLANT. IT WAS REPORTED THAT APPROXIMATELY SIX MONTHS POST IMPLANT THE PATIENT WAS FOUND TO HAVE LIMB THROMBOSIS. THE STENT GRAFT WAS ORIGINALLY IMPLANTED IN A PRETZEL TYPE VESSEL CONFIGURATION. THE PATIENT ALSO HAD A TIGHT SPOT IN THE DISTAL LEFT COMMON ILIAC ARTERY BY THE ILIAC BIFURCATION THAT MIGHT HAVE CONTRIBUTED. THE LIMB HAD BEEN THROMBOSED AND THE CLOT WAS ORGANIZED. THE PHYSICIAN ENDED UP PUTTING TWO ENDURANT LIMBS UP TO THE TOP OF THE BIFURCATED GRAFT BECAUSE THERE WAS A LOT OF CLOT IN THE BODY OF THE STENT GRAFT AND PLACED TWO 9 X 39 STENTS FROM ANOTHER MANUFACTURER, ONE IN THE AREA BY THE GATE WHERE THE COMPRESSION OF THE LEFT LIMB WAS SIGNIFICANT, AND ONE IN THE DISTAL LEFT COMMON/PROXIMAL EXTERNAL. THE OCCLUSION WAS SUCCESSFULLY RESOLVED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE. REVIEW OF SEVERAL RETURNED STILL CT IMAGES SHOW THAT THE LEFT LIMB IS COMPRESSED TO 6MM, AND OCCLUDED DISTALLY INTO THE LEFT ILIAC. THE START OF THE OCCLUSION COULD NOT BE DETERMINED. THE RIGHT LIMB WAS PATENT. THE CAUSE OF THE COMPRESSION, WHICH LIKELY CONTRIBUTED TO THE OCCLUSION, COULD NOT BE DETERMINED, BUT THERE WAS EVIDENCE OF VESSEL CALCIFICATION. IMAGES POST-SECONDARY PROCEDURE WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354402 ENDURANT II SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V03016884

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Required Intervention