BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPLETE SE SFA

    MDR report key: 4647164 · Received April 1, 2015

    Report

    Report Number
    9612164-2015-00456
    Event Type
    Malfunction
    Date Received
    April 1, 2015
    Date of Event
    March 3, 2015
    Report Date
    March 3, 2015
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIP
    PMA / PMN Number
    P090006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: (ROOT CAUSE UNDETERMINED). NO RESULTS AVAILABLE SINCE NO EVALUATION WAS PERFORMED (DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR REVIEW). EVALUATION CONCLUSION: (ROOT CAUSE UNDETERMINED). UNABLE TO CONFIRM COMPLAINT (DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR REVIEW). (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT A COMPLETE SE STENT WAS IMPLANTED SUCCESSFULLY IN THE DISTAL SUPERFICIAL FEMORAL ARTERY BUT DIFFICULTIES WERE ENCOUNTERED DURING REMOVAL OF THE DELIVERY SYSTEM FOLLOWING STENT DEPLOYMENT. THE SFA VESSEL WAS REPORTED AS HAVING MODERATE TORTUOSITY. IT WAS REPORTED THAT AFTER STENT DEPLOYMENT THE TIP OF THE CATHETER GOT CAUGHT ON THE STENT STRUTS. THE PHYSICIAN HAD TO RECAPTURE THE DELIVERY SYSTEM AND THEN PULLED OUT THE STENT DELIVERY CATHETER. THE COMPLETE SE STENT HAD BEEN INSPECTED AND PREPPED PRIOR TO USE WITH NO ABNORMALITIES NOTED. THE DEVICE HAD PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO REPORTED PATIENT COMPLICATIONS OR CLINICAL SEQUELAE WERE REPORTED FOR THIS EVENT. THE STENT REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216043 COMPLETE SE SFA STENT, SUPERFICIAL FEMORAL ARTERY NIP MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1