BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPLETE SE SFA

    MDR report key: 4000926 · Received August 12, 2014

    Report

    Report Number
    9612164-2014-01067
    Event Type
    Malfunction
    Date Received
    August 12, 2014
    Date of Event
    March 7, 2014
    Report Date
    August 12, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIP
    PMA / PMN Number
    P110040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: ROOT CAUSE OF THE ISSUE IS UNDETERMINED. INHERENT RISK OF PROCEDURE (STENT MIGRATION). NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED- DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR REVIEW. NO DEVICE RETURNED. EVALUATION CONCLUSION: KNOWN INHERENT RISK OF PROCEDURE (STENT MIGRATION). UNABLE TO CONFIRM COMPLAINT - DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR REVIEW. ROOT CAUSE OF THE ISSUE IS UNDETERMINED. (B)(4).

    Description of Event or Problem · 1

    THE LESION EXHIBITED GREATER THAN 50% STENOSIS. NO DIFFICULTIES ENCOUNTERED DURING PREPARATION OF THE DEVICE BEFORE USE. NO ISSUES NOTED WHEN THE DEVICE WAS INSERTED INTO THE PATIENT PRIOR TO DEPLOYMENT OF THE STENT. NO EXTRA FORCED USED TO DELIVER/CROSS THE LESION.

    Description of Event or Problem · 1

    THE PHYSICIAN WAS PERFORMING SUB INTIMAL ANGIOPLASTY OF AN OCCLUDED LEFT SUPERFICIAL FEMORAL ARTERY (SFA). ACCESS WAS GAINED PERFORMED VIA RIGHT GROIN UP AND OVER WITH NON- MEDTRONIC 6 FR SHEATH. DIFFICULT PROCEDURE BUT RE-ENTERED LUMEN BEYOND OCCLUSION AND CONFIRMED INTRALUMINAL POSITION WITH ANGIOGRAPHY. 5000 UNIT¿S HEPARIN WAS GIVEN. PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WITH A NON-MEDTRONIC BALLOON FOLLOWED BY A COMPLETE SE STENT WAS CARRIED OUT. THE RED SAFETY LOCK WAS REMOVED FROM THE COMPLETE SE DEVICE. WHEN THE REGISTRAR STARTED TURNING THE KNOB IT WOULD NOT ENGAGE. THE PHYSICIAN TOOK OVER AND BY PULLING BACK WHILST TURNING, THE KNOB ENGAGED AND THE SHEATH PEELED BACK. THE LAST SEGMENT WAS RELEASED BY PUSHING THE TWO BUTTONS AND MOVING THE KNOB BACK WITHOUT TURNING. STENT HAD FULLY DEPLOYED. ON TRYING TO REMOVE THE DEVICE, THE STENT GOT PULLED BACK WITH IT INTO THE SHEATH. THE ENTIRE DEVICE WAS REMOVED WITH THE SHEATH. THE PHYSICIAN WAS ABLE TO MAINTAIN WIRE ACCESS AND COMPLETE THE CASE WITH A GOOD RESULT. NO PATIENT INJURY OR OTHER CLINICAL SEQUELAE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480765 COMPLETE SE SFA STENT, SUPERFICIAL FEMORAL ARTERY NIP MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1