BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT

    MDR report key: 3112372 · Received May 14, 2013

    Report

    Report Number
    2953200-2013-00885
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    January 8, 2011
    Report Date
    April 19, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: FILM EVALUATION. RESULTS: ENDOLEAK. INSUFFICIENT STENT GRAFT OVERLAP. CONCLUSION: INSUFFICIENT STENT GRAFT OVERLAP. ENDOLEAK.

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM AND VESSEL MORPHOLOGY WERE DESCRIBED AS UNREMARKABLE. IT WAS REPORTED THAT 4 STENT GRAFTS WERE IMPLANTED WITHOUT COMPLICATIONS. ACT WAS DONE 1 DAY POST IMPLANT AND THE PHYSICIAN SAW AIR BUBBLE TRAPPED BETWEEN THE STENT GRAFT AND THE AORTA IN A FEW SPOTS. THE PHYSICIAN DOES NOT THINK THE AIR BUBBLES ARE RELATED TO INFECTION, THE PATIENT DID NOT HAVE A PRE-EXISTING INFECTION AND DOES NOT HAVE INFECTION NOW. CLINICALLY THE PATIENT IS ASYMPTOMATIC AND IS DOING FINE. IT WAS REPORTED THAT AT THE INDEX PROCEDURE THE FINAL ANGIOGRAM RUN SHOWED 2 TO 2.5 CM OF OVERLAP AND NO ENDOLEAK WAS PRESENT. CURRENTLY, AN ANGIOGRAM PERFORMED SHOWED THAT THERE WAS A TYPE III ENDOLEAK, SEPARATION BETWEEN THE LEFT CONTRALATERAL LIMB AND CONTRALATERAL EXTENSION. AN ENDURANT II WAS SUCCESSFULLY IMPLANTED TO BRIDGE THE STENT GRAFTS AND REPAIR THE ENDOLEAK. THE PHYSICIAN THINKS THAT THE EVENT WAS CAUSED BY THE LACK OF OVERLAP AT THE INDEX PROCEDURE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE. A REVIEW OF A SINGLE RETURNED ANGIOGRAM IMAGE AT IMPLANT SHOWS THAT THE CONTRALATERAL EXTENSION IN THE LEFT ILIAC IS OVERLAPPING THE CONTRALATERAL LIMB BY APPROXIMATELY 1.5CM. A SINGLE STILL ANGIOGRAM IMAGE FROM A CURRENT STUDY NOW SHOWS THAT THE CONTRALATERAL EXTENSION HAS SEPARATED FROM THE CONTRALATERAL LIMB. THE CONTRALATERAL EXTENSION IS ALSO NOTICEABLY MORE ANGULATED COMPARED TO THE IMAGE AT IMPLANT. IMAGES SHOWING POST RE-LINING OF THE LIMB SEPARATION WERE NOT PROVIDED. THE LIKELY CAUSE OF THE SEPARATION IS INSUFFICIENT DEVICE OVERLAP AT IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212936 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V00553733

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR Required Intervention