BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2003587 · Received February 22, 2011

    Report

    Report Number
    2953200-2011-00477
    Event Type
    Injury
    Date Received
    February 22, 2011
    Date of Event
    January 25, 2011
    Report Date
    January 25, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: (ENDOLEAK), (SEVERE ILIAC ARTERY ANGULATION, 80 DEGREES), (INADEQUATE DEVICE OVERLAP WITH NO ADJUSTMENT FOR PARALLAX). EVAL, CONCLUSION: (SEVERE ILIAC ARTERY ANGULATION, 80 DEGREES), (INADEQUATE DEVICE OVERLAP WITH NO ADJUSTMENT FOR PARALLAX).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYS WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. VESSEL MORPHOLOGY WAS REPORTED AS THE AORTIC NECK WAS 3.5 CM LONG AND HAD A 60 DEGREE ANGULATION AND IT WAS 22 MM IN DIAMETER PROXIMALLY AND 23 MM DISTALLY. THE ILIAC ARTERIES HAD 80 DEGREE ANGULATION BILATERALLY. THE RIGHT ILIAC ARTERY WAS 36 MM PROXIMALLY, 30 MM MID, AND 25 MM DISTALLY IN DIAMETER. THE LEFT ILIAC ARTERY WAS 30 MM PROXIMALLY, 27 MM MID AND 21 MM IN DISTALLY IN DIAMETER, FOR 2 CM LENGTH. IT WAS REPORTED THAT WHEN THE BIFURCATED STENT GRAFT WAS DEPLOYED THE PHYSICIAN ROTATED THE WHEEL TO RELEASE THE SUPRA RENAL STENTS. THE PHYSICIAN WENT TO CAPTURE THE NOSE CONE AND ROTATED THE DELIVERY SYS COUNTER CLOCKWISE AND PUSHED UP; HOWEVER, ONE OF THE SUPRA RENAL STENTS WAS STILL WITHIN THE SLEEVE. THE WHEEL WAS NOT ROTATED ON THE WAY BACK, BUT THE SUPRA RENAL STENTS APPEARED FULLY RELEASED. AS THE PHYSICIAN TWISTED THE TOP OF THE DELIVERY CATHETER THE BIFURCATED STENT GRAFT WAS TWISTING. THE PHYSICIAN STOPPED AND ROTATED THE DELIVERY SYS CLOCKWISE. THE PHYSICIAN ROTATED THE WHEEL FULLY AND USED A BALLOON TO RELEASE THE SUPRA RENAL STENT AND REMOVED THE DELIVERY SYS FROM THE PT. THERE WAS NO ENDOLEAK OR STENT GRAFT MOVEMENT; HOWEVER, TWO OF THE SUPRA RENAL STENTS WERE OVERLAPPING. IT WAS ALSO REPORTED THAT WHEN THE CONTRALATERAL LIMB WAS DEPLOYED THERE WAS A TYPE 3 ENDOLEAK BETWEEN THE BIFURCATED STENT GRAFT AND THE ILIAC LIMB STENT GRAFT. THIS WAS ATTRIBUTED TO THE SEVERE ANGULATION OF THE ILIAC ARTERY AND BECAUSE THEY DID NOT ADJUST FOR PARALLAX EVEN THOUGH THERE WAS 2 CM OVER LAP (REF MFR#2953200-2011-00476). AN ADDITIONAL ILIAC LIMB WAS IMPLANTED AT THE JUNCTION BETWEEN THE GATE AND THE CONTRALATERAL LIMB AND SUCCESSFULLY RESOLVED THE ENDOLEAK. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT ABDOMINAL STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00551197

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK