BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2023338 · Received March 16, 2011

    Report

    Report Number
    2953200-2011-00645
    Event Type
    Injury
    Date Received
    March 16, 2011
    Date of Event
    February 14, 2011
    Report Date
    February 14, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: (ENDOLEAK). CONCLUSION: (AREA OF CALCIFICATION AND A POSSIBLE FUNNEL-SHAPE).

    Description of Event or Problem · 1

    AN ENDURANT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A 7.38 CM ABDOMINAL AORTIC ANEURYSM, APPROX 1 MONTH AGO. VESSEL MORPHOLOGY WAS REPORTED AS THE PROXIMAL NECK HAVING CIRCUMFERENTIAL MURAL THROMBUS WITH SOME AREAS OF CALCIFICATION AND A POSSIBLE FUNNEL-SHAPE. IT WAS REPORTED THAT THE IMPLANT PROCEEDED WELL AND WITHOUT DIFFICULTY. A BALLOON WAS USED AT THE ATTACHMENT AND OVERLAP POINTS. A '2020X82' STENT GRAFT WAS USED TO EXTEND THE BIFURCATED LIMB ON THE RIGHT SIDE. THE POST IMPLANT ANGIOGRAM SHOWED IMMEDIATE STREAMING OF CONTRAST INTO THE ANEURYSM SAC. SUBSEQUENT ANGIOGRAMS WERE OBTAINED BY PULLING THE CATHETER FULLY INTO THE GRAFT WITH AN APPROPRIATE ANGLE HIGHLIGHTING THE STREAMING OF CONTRAST ORIGINATING FROM THE BIFURCATED STENT GRAFT, APPROXIMATELY 2.5 CM DISTAL TO THE PROXIMAL MAKERS AND FULLY ON THE RIGHT SIDE OF THE GRAFT. IT WAS DETERMINED THIS WAS A TYPE 3 FABRIC ENDOLEAK. A 36X36X49 CUFF WAS PLACED WITHOUT DIFFICULTY AND BALLOONED. THE NEXT ANGIOGRAM REVEALED COMPLETE RESOLUTION OF THIS ENDOLEAK AND SUCCESSFUL EVAR. THE EXACT CAUSE OF THIS ENDOLEAK CANNOT BE DETERMINED, BUT THE PHYSICIAN STATED THAT THE CALCIFICATION COULD HAVE CAUSED IT. NO FURTHER CLINICAL SEQUELAE HAVE BEEN PROVIDED AND THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT ABDOMINAL STENT GRAFT SYSTEM MIH MEDTRONIC IRELAND NA V00804838

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention