BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2023367 · Received March 16, 2011

    Report

    Report Number
    2953200-2011-00647
    Event Type
    Injury
    Date Received
    March 16, 2011
    Date of Event
    February 15, 2011
    Report Date
    February 15, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: (ARTERIAL/VESSEL OCCLUSION); (SMALL EXTERNAL ILIACS). EVAL, CONCLUSION: (SMALL EXTERNAL ILIACS).

    Description of Event or Problem · 1

    AN ENDURANT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROX 60 DAYS AGO. THE DEVICE WENT IN WITH NO PROBLEM. THE PT HAD SMALL EXTERNAL ILIACS. NO OTHER ANEURYSM AND VESSEL MORPHOLOGY WERE REPORTED. THE IMAGES DURING THE CASE LOOKED FINE WITH NO EVIDENCE OF ANY PROBLEMS IN THE ILIACS. THE CT SCAN THAT THE PT HAD PRE-DISCHARGE ALSO LOOKED GOOD AND THE ILIAC LIMBS LOOKED FINE. THERE WAS NO EVIDENCE OF ANY KINKS. IT WAS REPORTED THAT THE PT RETURNED TO CLINIC ONE MONTH LATER COMPLAINING OF PAIN IN HIS LEFT LEG. THE PHYSICIAN PERFORMED A DUPLEX SCAN AND FOUND THAT THE LEFT LIMB OF THE STENT GRAFT WAS OCCLUDED. THE RADIOLOGIST MANAGED TO EXTRACT THE THROMBUS AND THUS OPENED THE OCCLUDED LIMB BY USING THE THROMBECTOMY SYSTEM. THE GRAFT WAS THEN BALLOONED. THERE WAS A SMALL KINK IN THE STENT, SO ANOTHER MFR'S STENT WAS IMPLANTED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED 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 V00809667

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention