BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT STENT GRAFT SYSTEM

    MDR report key: 2840861 · Received November 20, 2012

    Report

    Report Number
    2953200-2012-02251
    Event Type
    Injury
    Date Received
    November 20, 2012
    Date of Event
    October 26, 2012
    Report Date
    October 26, 2012
    Manufacturer
    MEDTRONIC IRELAND
    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). METHOD: (FILM). RESULTS: INHERENT RISK OF PROCEDURE (STENT GRAFT INFOLD); PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (LIKELY DUE TO TAPERED AORTIC NECK). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (LIKELY DUE TO TAPERED AORTIC NECK).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 4 CM DIAMETER ABDOMINAL AORTIC ANEURYSM AND A RIGHT ILIAC ANEURYSM APPROXIMATELY THREE MONTHS AGO. IT WAS REPORTED THAT DURING AN IVIS IMAGING, THE PHYSICIAN NOTED SIGNIFICANT STENT GRAFT INFOLD. THE PHYSICIAN DECIDED TO IMPLANT A PALMAZ STENT IN THE PROXIMAL PART OF THE ENDURANT BIFURCATED STENT GRAFT ((B)(4)) AND DISTAL TO THE RENAL ARTERIES. THE POSSIBLE CAUSE OF THE INFOLDING WAS DUE TO THE DISTAL AORTA TAPERING DOWN. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE. REVIEW OF RETURNED CINE DURING IMPLANT SHOWS SIGNIFICANT STENT GRAFT INFOLDING WITHIN THE BIFURCATE AORTIC BODY. REVIEW OF SINGLE FINAL ANGIO IMAGE WAS INCONCLUSIVE DUE TO THE POOR QUALITY. THE CAUSE OF THE INFOLDING IS UNKNOWN; HOWEVER, IT IS POSSIBLE THAT STENT GRAFT OVERSIZING MAY HAVE CONTRIBUTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01052403

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR Required Intervention