BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2882699 · Received December 20, 2012

    Report

    Report Number
    2953200-2012-02449
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    November 16, 2012
    Report Date
    January 3, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: INHERENT RISK OF PROCEDURE (STENT GRAFT OCCLUSION); CAUSED BY ANOTHER DRUG/DEVICE (SURGICAL CROSS OVER GRAFT WAS OCCLUDED). CONCLUSION: ANOTHER DEVICE CAUSED FAILURE (SURGICAL CROSS OVER GRAFT WAS OCCLUDED).

    Additional Manufacturer Narrative · 1

    METHOD: (FILM). RESULTS: PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (CALCIFIED VESSELS BILATERALLY). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (CALCIFIED VESSELS BILATERALLY).

    Description of Event or Problem · 1

    FILMS WERE RECEIVED AND REVIEWED. REVIEW OF ANGIO IMAGES FROM THE TIME OF IMPLANT SHOW THAT THE AUI WAS IMPLANTED INTO THE RIGHT ILIAC ARTERY AND AN OCCLUDER WAS PLACED IN THE LEFT COMMON ILIAC. COMPLETION ANGIO SHOWED MILD STENT GRAFT NARROWING IN THE RIGHT COMMON ILIAC; HOWEVER, NO STENT GRAFT KINKS WERE SEEN AND THERE APPEARED TO BE GOOD DISTAL RUNOFF. REVIEW OF CTA'S POST-IMPLANT SHOWED THAT THE STENT GRAFT WAS COMPLETELY OCCLUDED BEGINNING JUST BELOW THE STENT GRAFT PROXIMAL MARGIN; JUST BELOW THE RENALS. THERE WAS SLIGHT NARROWING IN THE ILIAC AREA OF THE STENT GRAFT (APPROXIMATELY 8MM ID), BUT THERE WERE NO KINKS OBSERVED. THE FEM-FEM BYPASS GRAFT WAS ALSO OCCLUDED; HOWEVER, THE PATIENT'S RIGHT AND LEFT LEGS WERE BEING PERFUSED DISTAL TO THE FEM-FEM VIA COLLATERAL ARTERIES. THE PATIENT'S LIMB VESSELS WERE VERY CALCIFIED BILATERALLY. THE MAXIMUM AAA DIAMETER WAS 8CM. THE CAUSE OF THE OCCLUSION COULD NOT BE DETERMINED FROM THESE FILMS. THIS MAY HAVE BEEN CAUSED BY A PATIENT CONDITION.

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS INSERTED INTO A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 6.7 CM ABDOMINAL AORTIC ANEURYSM APPR OXIMATELY FOUR MONTHS AGO. VESSEL MORPHOLOGY WAS NOT REPORTED. IT WAS REPORTED THAT APPROXIMATELY ONE MONTH AGO THE PATIENT PRESENTED WITH BILATERAL ISCHEMIA AND WITH OCCLUSION IN THE STENT GRAFT. THE MAIN BODY LIMB WAS BLOCKED AND SO WAS THE SURGICAL CROSS OVER GRAFT. THE PHYSICIANS ARE PLANNING TO UNBLOCK THE CROSS OVER GRAFT AND USE A STENT GRAFT TO BYPASS FROM THE PATIENT AXILLA TO THE FEMORAL. NO FURTHER INFORMATION WAS PROVIDED. PLEASE NOTE THAT THIS MODEL NUMBER ENUF2514C150EE IS NOT APPROVED IN THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE ENBF2513C145EE WHICH IS APPROVED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01076597

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Required Intervention