BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPLETE SE SFA

    MDR report key: 4529964 · Received February 20, 2015

    Report

    Report Number
    9612164-2015-00273
    Event Type
    Malfunction
    Date Received
    February 20, 2015
    Date of Event
    January 23, 2015
    Report Date
    April 27, 2015
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIP
    PMA / PMN Number
    P110040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: RELATED TO ANOTHER DRUG/DEVICE (KINK ON THE INTRODUCER SHEATH MAY HAVE HINDERED ADVANCEMENT OF DEVICE). (B)(4)

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: DEFORMATION PROBLEM (STENT).

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: PATIENT CONDITION AFFECTED EFFECTIVENESS OF DEVICE (80% LESION STENOSIS, SEVERELY CALCIFIED LESION AND SEVERELY TORTUOUS VESSEL). FAILURE TO FOLLOW INSTRUCTIONS (APPLYING EXCESSIVE FORCE CAN POTENTIALLY RESULT IN PARTIAL DEPLOYMENT OF THE STENT AS LISTED IN IFU). (NO DEVICE RETURNED FOR EVALUATION). EVALUATION CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (80% LESION STENOSIS, SEVERELY CALCIFIED LESION AND SEVERELY TORTUOUS VESSEL). FAILURE TO FOLLOW INSTRUCTIONS (APPLYING EXCESSIVE FORCE CAN POTENTIALLY RESULT IN PARTIAL DEPLOYMENT OF THE STENT AS LISTED IN IFU). UNABLE TO CONFIRM COMPLAINT (NO DEVICE OR CINE IMAGES RETURNED FOR EVALUATION). (B)(4).

    Description of Event or Problem · 1

    EVALUATION SUMMARY: THE FIRST TWO DISTAL STENT SEGMENTS WERE EXPOSED AND DEPLOYED. VISUAL INSPECTION OF THE DEVICE HANDLE CONFIRMED THE RED SAFETY CLIP WAS PRESENT ON THE RETURNED DEVICE. A GAP WAS EVIDENT BETWEEN THE BLUE SLIDER AND THE FRONT GRIP. VISUAL INSPECTION CONFIRMED THAT THE DISTAL STENT MARKERS WERE FURTHER ADVANCED THAN THE DISTAL CATHETER MARKER BAND. ATTEMPTS TO LOAD THE RETURNED DEVICE INTO A PROTECTIVE HOOP WITH DIMENSIONS THE SAME AS THAT USED DURING THE MANUFACTURE OF THIS BATCH FAILED DUE TO THE DEPLOYMENT OF THE FIRST TWO DISTAL STENT SEGMENTS CONFIRMING THAT THE DEVICE DID NOT LEAVE THE MANUFACTURING FACILITY IN ITS RETURNED STATE.

    Description of Event or Problem · 1

    PHYSICIAN WAS ATTEMPTING TO TREAT A LESION IN THE MID RIGHT SUPERFICIAL FEMORAL ARTERY USING A COMPLETE SE STENT SYSTEM. THE LESION WAS SEVERELY CALCIFIED WITH 80% STENOSIS, THE VESSEL WAS SEVERELY TORTUOUS. THE DEVICE WAS REMOVED FROM THE PACKAGING, INSPECTED AND PREPPED PER THE IFU WITH NO ISSUES NOTED. IT WAS REPORTED THAT PHYSICIAN WAS DOING AN ANTEGRADE DEPLOYMENT IN THE SFA AND THE SHEATH IN THE PATIENT'S GROIN WAS KINKED. THERE WAS TORTUOSITY GETTING DOWN TO THE SFA. THE PHYSICIAN COULD NOT GET THE STENT SHAFT TO THE PART OF THE SFA TO BE STENTED, THE STENT KEPT GETTING CAUGHT. EXCESSIVE FORCE WAS USED DURING DELIVERY AND RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. PHYSICIAN THEN REMOVED THE WHOLE SYSTEM AND IT WAS NOTED THAT THE STENT HAD STARTED TO DEPLOY. BALLOONING WAS PERFORMED AND ANOTHER COMPLETE SE DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121474 COMPLETE SE SFA STENT, SUPERFICIAL FEMORAL ARTERY NIP MEDTRONIC IRELAND 0007303578

    Patients

    Seq Age Sex Outcome Treatment
    1