BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABSOLUTE PRO .035 SELF EXPANDING STENT SYSTEM

    MDR report key: 2130312 · Received June 16, 2011

    Report

    Report Number
    2024168-2011-04224
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    May 13, 2011
    Report Date
    May 24, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    FGE
    PMA / PMN Number
    K072708
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. POSSIBLE CAUSES FOR DIFFICULTY WITHDRAWING THE CATHETER THROUGH THE INTRODUCER SHEATH INCLUDE, BUT ARE NOT LIMITED TO, DAMAGE TO THE CATHETER OR INTRODUCER SHEATH, KINKED CATHETER OR GUIDE WIRE, AND PHYSICIAN TECHNIQUE. IN THIS CASE, THE DEVICE AND ACCESSORY DEVICES WERE NOT RETURNED SO NO DEFINITIVE CAUSE COULD BE DETERMINED. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS REVEALED NO NONCONFORMING MATERIAL RECORDS AND NO SIMILAR INCIDENTS WERE REPORTED FOR THIS LOT. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO SIMILAR INCIDENTS REPORTED FOR THIS LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). RADIAL ACCESS WAS PERFORMED, AND THE ABSOLUTE PRO STENT WAS SUCCESSFULLY PLACED AT THE LESION IN THE SFA. DURING REMOVAL OF THE STENT DELIVERY SYSTEM, RESISTANCE WAS MET WITH THE INTRODUCER; THEREFORE, THE DELIVERY SYSTEM AND INTRODUCER WERE REMOVED AS A SINGLE UNIT. THERE WERE NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABSOLUTE PRO .035 SELF EXPANDING STENT SYSTEM SELF EXPANDING STENT SYSTEM FGE AV-TEMECULA-CT 0062151

    Patients

    Seq Age Sex Outcome Treatment
    1 OTHER: INTRODUCER: CORDIS 6 FR 11 CM