BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT

    MDR report key: 3241459 · Received July 22, 2013

    Report

    Report Number
    2953200-2013-01412
    Event Type
    Injury
    Date Received
    July 22, 2013
    Date of Event
    March 26, 2012
    Report Date
    June 27, 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: OCCLUSION. ANATOMY RELATED; ACCESS VESSELS. CONCLUSION: OCCLUSION. ANATOMY RELATED; ACCESS VESSELS.

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 5 CM ABDOMINAL AORTIC ANEURYSM. ANGLE BETWEEN THE PROXIMAL AAA AORTIC NECK AND THE SUPRARENAL AORTIC AXIS IS 20 DEGREES. PROXIMAL NON-ANEURYSMAL AORTIC NECK DIAMETER, IMMEDIATELY BELOW THE LOWEST RENAL IS 24 MM. DISTAL DIAMETER OF AORTA/ANEURYSM ABOVE THE AORTIC BIFURCATION WAS 21 MM. DIAMETER OF NON-ANEURYSMAL NECK OF RIGHT ILIAC ARTERY WAS 8 MM. DISTAL DIAMETER OF NON-ANEURYSMAL NECK OF RIGHT ILIAC ARTERY WAS 8 MM. DIAMETER OF THE ACCESS VESSELS, RIGHT FEMORAL ARTERY WAS 7.5 MM. DIAMETER OF NON-ANEURYSMAL NECK OF LEFT ILIAC ARTERY WAS 7.5 MM. DISTAL DIAMETER OF NON-ANEURYSMAL NECK OF LEFT ILIAC ARTERY WAS 9 MM. DIAMETER OF THE ACCESS VESSELS, LEFT FEMORAL ARTERY WAS 9 MM. LENGTH OF THE NON-ANEURYSMAL AORTIC NECK WAS 28 MM. LENGTH FROM THE LOWEST RENAL ARTERY TO AORTIC BIFURCATION WAS 87 MM. THE LENGTH OF THE PORTION OF THE RIGHT ILIAC FROM THE AORTIC BIFURCATION TO THE END OF THE SEAL ZONE IS 38 MM. THE LENGTH OF THE PORTION OF THE LEFT ILIAC FROM THE AORTIC BIFURCATION TO THE END OF THE SEAL ZONE IS 56 MM. RIGHT ILIAC ARTERY WAS TORTUOSITY WAS REPORTED AS MODERATE AND THE CALCIFICATION WAS REPORTED AS MODERATE. THE RIGHT ILIAC STENOSIS WAS 20% AND IN THE LEFT ILIAC 30%. CIRCUMFERENTIAL AORTIC NECK MURAL AT THE PROXIMAL AORTIC NECK WAS 20%. IT WAS REPORTED THAT DURING A ROUTINE FOLLOW-UP CT SCAN 3.5 YEARS POST INDEX PROCEDURE, OCCLUSION WAS FOUND IN THE RIGHT CONTRALATERAL ILIAC AND WAS LEFT UNCORRECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340310 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V00409752

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR