BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2113775 · Received June 2, 2011

    Report

    Report Number
    2953200-2011-01069
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    May 2, 2011
    Report Date
    May 2, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION: RESULTS: (DISSECTION), (CALCIFIED AND TORTUOUS VESSELS), (WITHDRAWAL OF THE DELIVERY CATHETER PRIOR TO COMPLETE TIP RECAPTURE). CONCLUSION: (CALCIFIED AND TORTUOUS VESSELS), (WITHDRAWAL OF THE DELIVERY CATHETER PRIOR TO COMPLETE TIP RECAPTURE).

    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. VESSEL MORPHOLOGY WAS CALCIFICATION AND TORTUOSITY THROUGH OUT THE VESSELS AND THE AORTIC NECK WAS SEVERELY ANGULATED. IT WAS REPORTED THE ENDURANT BIFURCATED STENT GRAFT WAS IMPLANTED VIA PERCUTANEOUS ACCESS, AND THE PHYSICIAN WAS MOVING VERY QUICKLY AND ATTEMPTED TO REMOVE THE DELIVERY SYSTEM PRIOR TO THE COMPLETE RETRACTION OF THE NOSECONE BACK INTO THE SHEATH. THE NOSECONE GOT CAUGHT ON A PIECE OF CALCIUM AT THE ACCESS SITE AND CAUSED A DISSECTION OF THE ILIAC ARTERY. THE PHYSICIAN PERFORMED A CUTDOWN ON THE GROIN AND SEWED IN A CONDUIT TO REPAIR THE ARTERY. THE DELIVERY SYSTEM WAS THEN REMOVED AFTER THE CUTDOWN WAS COMPLETED. THE PHYSICIAN ACKNOWLEDGED THAT IT WAS NOT A DEVICE ISSUE, AND THE EVENT WOULD NOT HAVE HAPPENED IF THE NOSE CONE WAS CORRECTLY RECAPTURED. 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 CARDIOVASCULAR GALWAY NA V00841111

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention