BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2893491 · Received January 2, 2013

    Report

    Report Number
    2953200-2013-00003
    Event Type
    Injury
    Date Received
    January 2, 2013
    Date of Event
    November 11, 2012
    Report Date
    January 2, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: ENDOLEAK. LACK OF INFORMATION. UNKNOWN CAUSE OF ENDOLEAK. CONCLUSIONS: LACK OF INFORMATION. UNKNOWN CAUSE OF ENDOLEAK.

    Description of Event or Problem · 1

    REVIEW OF RETURNED ANGIO IMAGES AT IMPLANT SHOW THAT THE LEFT ILIAC EXTENSION WAS PLACED INTO THE LEFT EXTERNAL; COVERING THE LEFT INTERNAL ILIAC ARTERY. THE DISTAL PORTION OF THE LEFT COMMON ILIAC IS DILATED. THERE IS AN ENDOLEAK SEEN FILLING THE LEFT INTERNAL ILIAC ARTERY WHERE THE ILIAC HAS DILATED. THE ENDOLEAK MAY BE A TYPE III FABRIC, BUT CANNOT RULE OUT A TYPE IV. POST-IMPLANT OF A CUFF WHICH RE-LINED THE LIMB SHOWED RESOLUTION OF THE ENDOLEAK.

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROXIMATELY TWO MONTHS AGO. ANEURYSM AND VESSEL MORPHOLOGY WERE NOT REPORTED. THE PROXIMAL NECK IS 21 TO 23 MM IN DIAMETER. THE VESSELS WERE NON TORTUOUS WITH LITTLE CALCIFICATION. IT WAS REPORTED THAT ON COMPLETION OF THE FINAL ANGIOGRAM AN ENDOLEAK WAS DISCOVERED. THE PHYSICIAN RE-BALLOONED WITH NO IMPROVEMENT SO IT WAS DECIDED THE ENDOLEAK WAS A TYPE III FABRIC COMING FROM THE CONTRALATERAL LIMB, APPROXIMATELY 4 STENTS FROM THE BOTTOM OF THE STENT GRAFT. CONTRAST WAS FILLING THE INTERNAL ILIAC ARTERY. THE PHYSICIAN RE-LINED THIS SEGMENT OF THE STENT GRAFT WITH AN ENDURANT ENLW1616C95EE AND RE-BALLOONED RESOLVING THE TYPE III ENDOLEAK. THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366 ENDURANT ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01031786

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Required Intervention