BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT

    MDR report key: 3250800 · Received July 29, 2013

    Report

    Report Number
    2953200-2013-01446
    Event Type
    Injury
    Date Received
    July 29, 2013
    Date of Event
    May 2, 2013
    Report Date
    July 2, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: INHERENT RISK OF PROCEDURE (PSEUDOANEURYSM); PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (ANATOMY RELATED; PSEUDOANEURYSM). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (ANATOMY RELATED; PSEUDOANEURYSM); KNOWN INHERENT RISK OF A PROCEDURE (PSEUDOANEURYSM); NO DEVICE FAILURE.

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 4.7 CM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. THE AORTIC NECK INFRA-RENAL ANGLE WAS 30 DEGREES. PROXIMAL AORTA WAS 22.7 MM IN DIAMETER AND 44 MM IN LENGTH. DISTAL AORTA WAS 21.4 MM IN DIAMETER. RIGHT ILIAC ARTERY DIAMETER AND THE LEFT ILIAC ARTERY DIAMETER WERE NOT REPORTED. THE RIGHT FEMORAL ARTERY WAS 10 MM IN DIAMETER AND THE LEFT FEMORAL ARTERY WAS 10.5 MM IN DIAMETER. IT WAS REPORTED ONE MONTH POST INDEX PROCEDURE THERE WAS A TECHNICAL OBSERVATION THAT THE PATIENT HAD A LEFT FEMORAL FALSE ANEURYSM AT THE PERCUTANEOUS ACCESS SITE. THERE WAS NO REPORTED INTERVENTION OR ACTION TAKEN. NO CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353484 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V03045717

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR