BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT

    MDR report key: 3050638 · Received April 10, 2013

    Report

    Report Number
    2953200-2013-00657
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    May 24, 2012
    Report Date
    March 14, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS: INHERENT RISK OF PROCEDURE (OCCLUSION). PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (ANATOMY RELATED; SMALL VESSELS). UNAPPROVED USE OF DEVICE (7 MM ILIAC ARTERY). EVALUATION CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (ANATOMY RELATED; SMALL VESSELS). OFF-LABEL, UNAPPROVED OR CONTRAINDICATED USE (7 MM ILIAC ARTERY).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. THE VESSEL MORPHOLOGY WAS REPORTED AS THE PROXIMAL NECK AND ANEURYSM ENTRANCE WAS 30MM IN DIAMETER. THE OUTSIDE VESSEL DIAMETER OF RIGHT COMMON ILIAC WAS 7MM AND THE VESSEL DIAMETER OF THE LEFT COMMON AND INTERNAL ILIAC WAS 20MM. THE MAXIMUM VESSEL DIAMETER OF THE RIGHT EXTERNAL ILIAC ARTERY WAS 7.5MM. THE COMBINED PROXIMAL NECK AND ANEURYSM LENGTH WAS 144MM. THE RIGHT COMMON ILIAC ARTERY LENGTH WAS 56MM AND THE LEFT COMMON ILIAC ARTERY LENGTH WAS 50MM. THE BIFURCATED STENT GRAFT WAS DEPLOYED AT THE INTENDED LANDING ZONE WITHOUT ISSUE. SIX MONTHS POST INDEX PROCEDURE, IT WAS NOTED THAT THE PATIENT HAD A RIGHT LIMB OCCLUSION DUE TO A TIGHT NARROW RIGHT FEMORAL ARTERY, RIGHT FEMORAL APPROACH AND EIA LANDING. THE PATIENT WAS CONFINED TO BED AND IT CAUSED BLOOD FLOW DECREASE. TEN MONTHS LATER THE PATIENT HAD A FEMORAL FEMORAL BYPASS. THE PHYSICIAN WILL MONITOR THE PATIENT. THE PATIENT IS FINE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152051 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Required Intervention