BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2130007 · Received June 10, 2011

    Report

    Report Number
    2953200-2011-01119
    Event Type
    Injury
    Date Received
    June 10, 2011
    Date of Event
    May 12, 2011
    Report Date
    May 12, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: (ENDOLEAK). (THE CAUSE OF THE UNKNOWN ENDOLEAK COULD NOT BE DETERMINED). (THE CAUSE OF THE UNKNOWN ENDOLEAK COULD NOT BE DETERMINED).

    Description of Event or Problem · 1

    AN ENDURANT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A GREATER THAN 5 CM ABDOMINAL AORTIC ANEURYSM APPROXIMATELY ONE MONTH AGO. VESSEL MORPHOLOGY WAS REPORTED AS THE AORTIC NECK WAS 20-23 MM IN DIAMETER AND 40-45 MM LONG. VESSEL TORTUOSITY AND CALCIFICATION WERE UNREMARKABLE. AFTER THE ENDURANT BIFURCATED STENT GRAFT (REF MFR# 2953200-2011-01117) WAS PLACED, A SUSPECTED TYPE III ENDOLEAK, DESCRIBED AS JETTING, WAS SEEN RIGHT ABOVE THE FLOW DIVIDER ON THE CONTRALATERAL SIDE OF MAIN BODY. DIFFERENT IMAGE ANGLES WERE MADE TO TRY TO DETERMINE THE TYPE OF ENDOLEAK; A TYPE I AND TYPE II WERE RULED OUT. IT MAY BE A HOLE IN THE STENT GRAFT. THE LOCATION OF THE LEAK WAS A HARD PLACE TO INTERVENE. AN ENDURANT CUFF (REF MFR# 2953200-2011-01118) WAS IMPLANTED PROXIMALLY, AND AN ENDURANT LIMB (REF MFR# 2953200-2011-01119) AS IMPLANTED UP THE CONTRALATERAL SIDE ABOVE THE FLOW DIVIDER; THE LEAK IMPROVED SLIGHTLY BUT WAS STILL PRESENT. TWO ADDITIONAL ILIAC LIMBS, ANOTHER MANUFACTURER'S ONE ON EACH SIDE WERE THEN ADDED TO TRY TO EFFECTIVELY MOVE UP THE FLOW DIVIDER FROM THE ORIGINAL FLOW DIVIDER OF THE ENDURANT MAIN BODY. THE ORIGINAL LEAK WAS STILL PRESENT AND THE AAA AND IMA COULD BE SEEN FILLING. NO FURTHER INTERVENTION WAS PERFORMED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE. FILMS FOR THIS CASE WERE REVIEWED INTERNALLY. REVIEW OF RETURNED FILMS POST-IMPLANT OF THE BIFURCATE STENT GRAFT SHOWED A LIKELY TYPE IV JETTING ENDOLEAK SEEN ON THE RIGHT SIDE OF THE AORTIC BODY ABOVE THE FLOW-DIVIDER. HOWEVER, THE POSSIBLE TYPE III FABRIC COULD NOT BE RULED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT ABDOMINAL STENT GRAFT SYSTEM MIH MEDTRONIC IRELAND NA V00838695

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention