BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANT II

    MDR report key: 3981839 · Received August 5, 2014

    Report

    Report Number
    2953200-2014-01520
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    June 11, 2014
    Report Date
    September 5, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PHYSICIAN ADVANCED THE DELIVERY SYSTEM WITH RESISTANCE. THE CAUSE OF THE RESISTANCE IS UNKNOWN. ONCE IN PLACE IT WAS IMPOSSIBLE TO DEPLOY THE STENT GRAFT BY ROTATING THE HANDLE. THE PHYSICIAN REMOVED THE DELIVERY SYSTEM FROM THE PATIENT AND IT APPEARED THE GRAFT COVER WAS BROKEN JUST BELOW WHERE THE STENT GRAFT WAS. PER THE PHYSICIAN THE CAUSE OF THE BREAK IS UNKNOWN. THE CASE WAS SUCCESSFULLY COMPLETED WITH ANOTHER ENDURANT DEVICE. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE. REVIEW OF RETURNED PRE-IMPLANT CTA'S REVEALED THAT THE PROXIMAL NECK DIAMETER JUST BELOW THE RENAL ARTERIES WAS APPROXIMATELY 28MM. THE AORTIC NECK WAS CALCIFIED; ESPECIALLY JUST ABOVE THE START OF THE ANEURYSM. THE MAXIMUM DIAMETER AAA WAS 7CM, AND THE DISTAL SAC WAS ALSO CALCIFIED. BOTH ILIAC ARTERIES WERE LARGE CALIBER, BUT WERE TORTUOUS AND CALCIFIED. IMAGES DURING IMPLANT WERE NOT PROVIDED. THE CAUSE OF THE POSITIONING DIFFICULTIES AND REPORTED BREAK DURING IMPLANT COULD NOT BE DETERMINED. IT IS POSSIBLE THAT THE CALCIFIED AND TORTUOUS ANATOMY MAY HAVE CONTRIBUTED. THIS MAY HAVE ALSO BEEN DUE TO A DELIVERY SYSTEM ISSUE. THE DEVICE WAS RETURNED AND ITS EVALUATION HAS BEEN COMPLETED. THERE WAS A BREAK IN THE GRAFT COVER AT THE GRAFT COVER BOND. THE ROOT CAUSE OF THE EVENT COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER, IS LIKELY MANUFACTURING RELATED.

    Description of Event or Problem · 1

    ADDITIONAL DEVICE ANALYSIS WAS PERFORMED AS FOLLOWS: THERE IS SEVERE DAMAGE TO THE GRAFT COVER. THE MULTIPLE KINKS AND TWISTS ALL ALONG THE GRAFT COVER LENGTH INDICATE A TORTUOUS PROCEDURE. THE SEVERE KINK ON THE GRAFT COVER AT THE POINT WHERE THE STENT GRAFT AND STOP MEET IS SIGNIFICANT IN RELATION TO THE DEPLOYMENT DIFFICULTY AND THE GRAFT COVER BOND/WELD BREAK. A SEVERE KINK OF THE GRAFT COVER AT THIS POINT ACTS AS AN ANCHOR POINT OF THE GRAFT COVER, PREVENTING STENT GRAFT DEPLOYMENT. TENSILE FORCE IS APPLIED TO THE GRAFT COVER DURING ATTEMPTED STENT GRAFT DEPLOYMENT. AS THE GRAFT COVER IS RESTRAINED BY THE KINKS, THIS WILL MOST LIKELY RESULT IN DEPLOYMENT DIFFICULTY AND POTENTIAL GRAFT COVER BREAK. IT IS LIKELY THAT THE CALCIFIED AND TORTUOUS ANATOMY RESULTED IN SEVERE DAMAGE TO THE DELIVERY SYSTEM THROUGH THE ACTION OF ADVANCING THE DELIVERY SYSTEM. THIS DAMAGE IS EVIDENT ON THE DEVICE. THIS DAMAGE WAS THE MAIN LIKELY CONTRIBUTOR TO THE DEPLOYMENT DIFFICULTY EXPERIENCED BY THE USER AND THE SUBSEQUENT GRAFT COVER BOND BREAK. FROM THE INVESTIGATION COMPLETED AND THE CHARACTERISTICS OF THE COMPLAINT UNIT IT IS LIKELY THAT THIS DEFECT IS NOT MANUFACTURING RELATED. THIS CONCLUSION IS BASED ON: THE SEVERE DAMAGED NOTED ON THE DELIVERY SYSTEM (ESPECIALLY KINK AT THE STENT STOP); CALCIFIED AND TORTUOUS ANATOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457881 ENDURANT II SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04257619

    Patients

    Seq Age Sex Outcome Treatment
    1