BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT AUI

    MDR report key: 3250884 · Received July 29, 2013

    Report

    Report Number
    2953200-2013-01442
    Event Type
    Injury
    Date Received
    July 29, 2013
    Date of Event
    May 22, 2013
    Report Date
    July 21, 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 (VESSEL OCCLUSION); PATIENT¿S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (ANATOMY RELATED). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (ANATOMY RELATED); KNOWN INHERENT RISK OF A PROCEDURE (VESSEL OCCLUSION).

    Description of Event or Problem · 1

    RE-INTERVENTION HAS BEEN PERFORMED A THROMBOEMBOLISM FROM THE CARDIAC ORIGIN (INTRA ATRIAL THROMBUS). ACCORDING TO PHYSICIAN, THERE IS NO RELATIONSHIP WITH STENT GRAFT.

    Description of Event or Problem · 1

    AN ENDURANT AUI STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A 5.3 CM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. LENGTH OF NON-ANEURYSM AORTIC NECK WAS 20 MM, PROXIMAL DIAMETER OF NON-ANEURYSM AORTIC NECK WAS 25 MM, DISTAL DIAMETER OF NON-ANEURYSMAL AORTIC NECK WAS 26 MM, DIAMETER OF ILIAC ANEURYSM WAS 21 MM, DIAMETER OF RIGHT ILIAC ARTERY WAS 14 MM, DIAMETER OF LEFT ILIAC ARTERY WAS 12 MM, DIAMETER OF RIGHT FEMORAL ARTERY WAS 11 MM, DIAMETER OF LEFT FEMORAL ARTERY WAS 8 MM. DEGREE OF CIRCUMFERENTIAL THROMBUS AND / OR CALCIFICATION WAS 10 PERCENT. IT WAS REPORTED THAT THE LEFT COMMON ILIAC ARTERY WAS OCCLUDED AND REQUIRED A RIGHT TO LEFT CROSS OVER BYPASS AT IMPLANT. THERE WAS A TECHNICAL OBSERVATION NOTED FOUR MONTH POST INDEX PROCEDURE. IT WAS REPORTED THAT A CT WITH CONTRAST REVEALED THERE WAS AN ARTERIAL OCCLUSION OF THE SUPERFICIAL FEMORAL ARTERIES BILATERALLY. THE ANEURYSM WAS 50 MM IN DIAMETER. NO INTERVENTION WAS PERFORMED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353908 ENDURANT AUI SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01005388

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Required Intervention