BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II

    MDR report key: 3041551 · Received April 8, 2013

    Report

    Report Number
    2953200-2013-00639
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 12, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: FILM EVALUATION; RESULTS: RISK OF PROCEDURE (ENDOLEAK); FAILURE TO FOLLOW INSTRUCTIONS (DEVICE OVERSIZING). CONCLUSION: OPERATIONAL CONTEXT CAUSED OR CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 5 CM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. THERE WAS 30 DEGREES OF ANGULATION IN THE PROXIMAL NECK. THE PROXIMAL AORTIC NECK WAS 24 MM IN DIAMETER AND 3 CM IN LENGTH. IT WAS REPORTED THAT THE MAIN BODY WAS PLACED; HOWEVER THERE WAS DIFFICULTY REMOVING THE DELIVERY SYSTEM. THE PHYSICIAN ROTATED THE DELIVERY SYSTEM COUNTER CLOCKWISE AND CLOCKWISE WITH NO LUCK. THE PHYSICIAN PULLED THE WIRE BACK WITH NO LUCK, HE THEN TRIED BALLOONING THE STENT GRAFT/DELIVERY SYSTEM OVER WITH NO LUCK. THE PHYSICIAN THEN ROTATED THE DEVICE PROXIMAL AND RECAPTURED THE DELIVERY SYSTEM ABOVE THE SUPRA RENAL STENT AND SUCCESSFULLY REMOVED THE DELIVERY SYSTEM. THE PHYSICIAN THEN PLACED THE CONTRALATERAL LIMB AND BALLOONED THE STENT GRAFTS. THE PHYSICIAN BALLOONED VERY AGGRESSIVELY. THE POST ANGIOGRAM SHOWED WHAT APPEARED TO BE A PROXIMAL TYPE I ENDOLEAK. THE PHYSICIAN PULLED DOWN AND DID AN ANGIOGRAM IN THE MAIN BODY OF THE GRAFT, WHICH SHOWED THE SAME ENDOLEAK. THE ANGIOGRAM SHOWED ABOUT 5 MM BETWEEN GRAFT AND RENAL ARTERIES. THE PHYSICIAN SAID HE WOULD FEEL BETTER IF HE PLACED A PROXIMAL CUFF. A PROXIMAL CUFF WAS PLACED TO TREAT THE ENDOLEAK. ON THE FINAL ANGIOGRAM THE LEAK WAS ALMOST RESOLVED. THE ENDOLEAK MAY HAVE BEEN CAUSED BY THE AGGRESSIVE BALLOONING. THE PATIENT STATUS IS UNKNOWN. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED. AN INTERNAL REVIEW OF 2 STILL ANGIOGRAM IMAGES SHOW THE BIFURCATE POSITIONED APPROXIMATELY 5 MM BELOW THE LEFT RENAL. THERE IS CONTRAST SEEN IN THE SAC; HOWEVER, THE SOURCE AND CAUSE OF THE ENDOLEAK COULD NOT BE DETERMINED FROM THIS SINGLE IMAGE. AN IMAGE POST-CUFF SHOWS THE CUFF IMPLANTED JUST BELOW THE RENAL ARTERIES; AN ASSESSMENT OF ANY POSSIBLE ENDOLEAK COULD NOT BE MADE FROM THIS IMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143303 ENDURANT II SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V03049232

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Required Intervention