BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2080587 · Received April 22, 2011

    Report

    Report Number
    2953200-2011-00873
    Event Type
    Injury
    Date Received
    April 22, 2011
    Date of Event
    March 22, 2011
    Report Date
    March 25, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: (ENDOLEAK). RESULTS & CONCLUSION: (DISEASE PROGRESSION AND AORTIC NECK DILATATION).

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROX EIGHT YEARS AGO. ANEURYSM AND VESSEL MORPHOLOGY AT THE TIME OF IMPLANT ARE UNK. THE ILIAC VESSELS HAVE SEVERE TORTUOSITY AND ARE SMALL IN DIAMETER. THERE WAS DISEASE PROGRESSION WITH AORTIC NECK DILATION NOTED FOUR MONTHS AGO. THE PT WAS LOST TO FOLLOW-UP AND WAS LAST SEEN ONE YEAR AFTER INITIAL IMPLANT. ON AN UNK DATE, THE CONTRALATERAL ILIAC STENT GRAFT LIMB WAS OCCLUDED AND A FEMORAL TO FEMORAL BYPASS WAS PERFORMED. A CT DEMONSTRATED THAT THE STENT GRAFT HAS MIGRATED WITH A TYPE I ENDOLEAK PRESENT (REF MFR # 2953200-2011-00006). AT THAT TIME, THE PHYSICIAN PLANNED TO TREAT THE PT WITH A TALENT CONVERTER STENT GRAFT. THE EXTERNAL ILIAC ARTERIES WERE SEVERELY CALCIFIED, SEVERELY TORTUOUS, AND NARROW MEASURING 5-6 MM IN DIAMETER. THE EXISTING OCCLUSION ON THE LEFT SIDE SEEMED DISTAL TO THE STENT GRAFT. AN INTERVENTION WAS ATTEMPTED ON THE RIGHT SIDE TO DELIVER A TALENT CONVERTER (REF MFR # 2953200-2011-00546); HOWEVER, THE DEVICE COULD NOT BE ADVANCED TO THE INTENDED LANDING ZONE. THERE WAS BALLOON DILATATION AND PUSHING, BUT THE DEVICE COULD NOT BE ADVANCED DUE TO THE EXTREME TORTUOSITY OF THE EXTERNAL ILIAC. THE DEVICE CRIMPED/KINKED. ANOTHER TALENT CONVERTER DEVICE (REF MFR # 2953200-2011-00547) ALSO COULD NOT BE DELIVERED AND KINKED. A 32 MM ENDURANT CUFF WAS ABLE TO BE DELIVERED AND COMPLETE THE CASE WITHOUT ISSUES AND RESOLVED THE TYPE I ENDOLEAK. APPROX ONE MONTH AGO FILMS WERE REVIEWED AND REVEALED THAT THERE IS A TYPE III ENDOLEAK BETWEEN THE ANEURX BIFURCATED STENT GRAFT (REF MFR # 2953200-2011-0006) AND THE ENDURANT AORTIC CUFF. THE CAUSE OF THE TYPE III ENDOLEAK IS DUE TO THE CONTINUED DISEASE PROGRESSION WITH AORTIC DILATION. THE PT WILL BE TREATED AT A LATER DATE. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT ABDOMINAL STENT GRAFT SYSTEM MIH MEDTRONIC IRELAND NA V00557975

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention