BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2882731 · Received December 20, 2012

    Report

    Report Number
    2953200-2012-02455
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    November 21, 2012
    Report Date
    November 21, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS: PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (EMBOLI). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (EMBOLI).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS INSERTED INTO A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 5.8 CM ABDOMINAL AORTIC ANEURYSM APPR OXIMATELY 11 MONTHS AGO. VESSEL MORPHOLOGY WAS NOT REPORTED. IT WAS REPORTED THAT APPROXIMATELY ONE MONTH AGO THE PATIENT PRESENTED WITH DISTAL EMBOLI DOWN THE RIGHT LEG WHICH WAS SUCCESSFULLY REMOVED BY AN EMBOLECTOMY. THE PHYSICIAN IS UNCERTAIN IF THIS EVENT WAS RELATED TO THE STENT GRAFT. THE PATIENT IS FINE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01001058

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Required Intervention