BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPLETE SE ILIAC

    MDR report key: 3904139 · Received July 1, 2014

    Report

    Report Number
    9612164-2014-00693
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    June 6, 2014
    Report Date
    July 2, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIO
    PMA / PMN Number
    P090006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: RELATED TO OPERATIONAL CONTEXT. DEFORMATION PROBLEM. EVALUATION CONCLUSION: OPERATIONAL CONTEXT CONTRIBUTED TO EVENT. (B)(4).

    Description of Event or Problem · 1

    DEVICE ANALYSIS: THE STENT HAD BEEN DEPLOYED IN THE PATIENT SO WAS NOT RETURNED AND THE RED SAFETY CLIP WAS NOT IN PLACE. THE INNER MEMBER APPEARS TO HAVE BEEN CUT APPROX. 17CM PROXIMAL TO THE DISTAL TIP. THE DETACHMENT SITE WAS IMMEDIATELY DISTAL TO THE BRAIDED SECTION OF THE INNER MEMBER. THE DISTAL TIP WAS BADLY DEFORMED AND TORN AT THE PROXIMAL AND DISTAL ENDS. THE INNER MEMBER WAS PINCHED/KINKED IN MULTIPLE LOCATIONS. THE FLOATING MARKER BAND WAS MISSING AND A SMALL PIECE OF THE FLOATING MARKER BAND CASING WAS RETURNED AND APPEARED TO HAVE BEEN CUT. THE OPERATION OF THE CATHETER WAS AS EXPECTED. THE TWISTING OF THE SLIDERS ON THE SCREW-GEAR WAS NORMAL. THE RETRACTION OF THE OUTER MEMBER AND STABILITY MEMBER OF THE CATHETER WAS AS EXPECTED AS THE HANDLE WAS TWISTED. THE SLIDER MOVEMENT WITH THE BUTTONS DEPRESSED WAS SLIGHTLY STIFF BUT THIS SEEMS TO BE DUE TO SOME DAMAGE TO THE END OF THE BRAIDED INNER WHERE IT HAS BEEN SEPARATED FROM THE NON-BRAIDED SECTION. THIS SLIGHT STIFFNESS IS NOT ENOUGH TO PREVENT THE DEPLOYMENT OF THE STENT.

    Description of Event or Problem · 1

    IT WAS REPORTED, A COMPLETE SE DEVICE WAS USED DURING A PROCEDURE TO TREAT A LESION IN THE LEFT SFA. THE DEVICE WAS INSPECTED PRIOR TO USE AND PREPPED WITH NO ISSUES NOTED. THE VESSEL WAS A LITTLE TORTUOUS AND WITH LITTLE CALCIFICATION. THE LESION WAS TOTALLY OCCLUDED (CTO, 100% OCCLUSION). THE DEVICE WAS ADVANCED TO THE TARGET LESION, BUT THE PHYSICIAN NOTED THAT DURING DEPLOYMENT, THE STENT DID NOT FULLY DEPLOY. IN AN ATTEMPT TO REMOVE THE DEVICE FROM THE PATIENT, PHYSICIAN ENCOUNTERED DIFFICULTIES REMOVING DEVICE AND NOTED THE STENT WAS DEFORMED IN VIVO. THE DEVICE WAS REMOVED BY PULLING IT BACK THROUGH THE SHEATH. PATIENT HAD AN AORTA BI-FEM SURGERY. THREE DAYS POST INDEX PROCEDURE, PATIENT EXPIRED DUE TO RELIGIOUS BELIEF TO NOT ACCEPT A BLOOD TRANSFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382169 COMPLETE SE ILIAC STENT, ILIAC NIO MEDTRONIC IRELAND 0006907071

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Death