BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPLETE SE SFA

    MDR report key: 5479440 · Received March 4, 2016

    Report

    Report Number
    9612164-2016-00225
    Event Type
    Malfunction
    Date Received
    March 4, 2016
    Date of Event
    February 5, 2016
    Report Date
    February 5, 2016
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIP
    PMA / PMN Number
    P110040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: THE CATHETER SHAFT WAS KINKED IMMEDIATELY DISTAL TO THE STRAIN RELIEF. THERE WAS NO FURTHER DAMAGE EVIDENT TO THE DEVICE. THERE WERE NO ISSUES NOTED OPERATING THE DEPLOYMENT MECHANISM WHEN RETRACTING THE SHEATH. (B)(4)

    Description of Event or Problem · 1

    THE PHYSICIAN WAS ATTEMPTING TO USE A COMPLETE SE STENT TO TREAT A MODERATELY CALCIFIED LEFT PROXIMAL SFA FIBROUS LESION EXHIBITING TOTAL OCCLUSION AND SLIGHT VESSEL TORTUOSITY. THE LESION HAD BEEN PRE-DILATED. THE DEVICE WAS REMOVED FROM ITS PACKAGING AND INSPECTED AND PREPPED AS PER IFU WITH NO ISSUES NOTED. THE DEVICE WAS KEPT STRAIGHT AND THE HANDLE FIXED DURING ATTEMPTED DEPLOYMENT. DURING THE PROCEDURE, THE PHYSICIAN REPORTED EXPERIENCING DEPLOYMENT DIFFICULTIES. A 6X150MM STENT HAD ALREADY BEEN DEPLOYED DISTALLY. THE COMPLETE SE 6X150MM STENT ENTERED PATIENT WITH MINIMAL OVERLAP PASSING THROUGH THE PREVIOUSLY DEPLOYED STENT. SEVERAL TURNS WERE MADE UNTIL STENT FLOWERED AS USUAL. THE TWO GRAY BUTTONS WERE DEPRESSED AND SLID ALL THE WAY BACK. THE PROXIMAL STENT DID NOT FULLY DEPLOY. DEVICE HANDLE WAS MOVED BACK AND FORTH SEVERAL TIMES. STENT FINALLY RELEASED AFTER ROTATING THE DEPLOYMENT KNOB SEVERAL TIME. THE STENT WAS FULLY EXPANDED PRIOR TO ATTEMPTING TO REMOVE THE DELIVERY SYSTEM. THE STENT WAS DEPLOYED AND THE DELIVERY SYSTEM WAS MANIPULATED DURING REMOVAL. NO COMPLICATIONS REPORTED TO HAVE FOLLOWED. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE AND NO EXCESSIVE FORCE USED DURING DELIVERY. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135270 COMPLETE SE SFA STENT, SUPERFICIAL FEMORAL ARTERY NIP MEDTRONIC IRELAND 0007823954

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR