BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANT II

    MDR report key: 3102649 · Received May 9, 2013

    Report

    Report Number
    2953200-2013-00867
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 11, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: INHERENT RISK OF PROCEDURE (KINK); PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (SEVERELY CALCIFIED VESSELS). CONCLUSION: INHERENT RISK OF A PROCEDURE (KINK); DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (SEVERELY CALCIFIED VESSELS).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS INSERTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. THE VESSELS WERE DESCRIBED AS DIFFICULT AND SEVERELY CALCIFIED. IT WAS REPORTED THAT DURING INSERTION OF THE ENDURANT ILIAC STENT GRAFT 161093 THE DELIVERY SYSTEM KINKED DUE TO THE SEVERELY CALCIFIED VESSELS. THE PHYSICIAN DECIDED TO REMOVE THE DELIVERY SYSTEM FROM THE PATIENT. PTA BALLOONS WERE USED TO DILATE THE VESSELS AFTER WHICH ANOTHER ENDURANT ILIAC STENT GRAFT 161082 DELIVERY SYSTEM WAS INSERTED AND SUCCESSFULLY DEPLOYED WITHOUT COMPLICATION. IT WAS ALSO NOTED THAT THERE WAS AN UNKNOWN TYPE OF ENDOLEAK AT THE END OF THE CASE. IT WAS REPORTED THAT ONE WEEK POST IMPLANT THE PATIENT CAME IN WITH LOWER ABDOMINAL PAIN DUE TO URINARY RETENTION. A CTA WAS DONE AT THAT TIME AND THE STENT GRAFTS LOOK GOOD AND NO ENDOLEAK WAS PRESENT. NO CLINICAL SEQUELAE WERE REPORTED AND IS FINE. THE DEVICE WAS RETURNED WITHIN THE ORIGINAL PACKAGING. THE DEVICE WAS RETURNED BLOODIED WITH THE STENT GRAFT LOADED WITHIN THE DELIVERY SYSTEM. UPON INSPECTION OF THE DELIVERY SYSTEM, THE DELIVERY SYSTEM HAD A LARGE CURVATURE DEFORMATION OF THE GRAFT COVER. THERE WERE MULTIPLE SMALL KINKS IN THE GRAFT COVER, STARTING AT THE EDGE OF THE GRAFT COVER AND ENDING 249 MM BACK. THERE WERE MULTIPLE KINKS IN THE GRAFT COVER. THE CAUSE OF THE KINKS COULD NOT BE CONCLUSIVELY DETERMINED, HOWEVER MOST LIKELY WERE CAUSED BY SEVERELY CALCIFIED AND TORTUOUS ACCESS VESSELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203572 ENDURANT II SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04004766

    Patients

    Seq Age Sex Outcome Treatment
    1