BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2032438 · Received March 25, 2011

    Report

    Report Number
    2953200-2011-00696
    Event Type
    Injury
    Date Received
    March 25, 2011
    Date of Event
    February 14, 2011
    Report Date
    February 23, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: (THROMBUS FORMATION). CONCLUSION: (ANTICOAGULATION MEDICATION INCREASED).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF ABDOMINAL AORTIC ANEURYSM 11 MONTHS AGO. ANEURYSM AND VESSEL MORPHOLOGY FROM THE TIME OF IMPLANT WERE NOT REPORTED. IT WAS REPORTED THAT THE INITIAL ENDURANT STENT GRAFT IMPLANTATION WAS SUCCESSFUL. ONE MONTH LATER A CT SCAN SHOWED NO SIGNIFICANT FINDINGS. SIX WEEKS AGO, A CT SCAN SHOWED THROMBUS FORMATION THROUGHOUT BOTH THE MAIN BODY (REF. MFR. 2953200-2011-00696) AND CONTRALATERAL LIMB (REF. MFR. 2953200-2011-00697). ANTICOAGULATION MEDICATION WAS INCREASED AND A MORE INTENSE FOLLOW-UP REGIMEN WILL BE CONDUCTED. THE GRAFT IS PATENT WITH GOOD PULSATIONS ON BOTH RIGHT AND LEFT FEMORAL ARTERIES. THE GRAFT REMAINS IN THE PATIENT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention