BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABSOLUTE PRO .035 SELF EXPANDING STENT SYSTEM

    MDR report key: 2102598 · Received May 25, 2011

    Report

    Report Number
    2024168-2011-03683
    Event Type
    Malfunction
    Date Received
    May 25, 2011
    Date of Event
    May 2, 2011
    Report Date
    May 2, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    FGE
    PMA / PMN Number
    K072708
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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. POTENTIAL FACTORS WHICH COULD CONTRIBUTE TO PREMATURE DEPLOYMENT PRIOR TO USE INCLUDE, BUT ARE NOT LIMITED TO, MANUFACTURING, INADVERTENTLY PULLING ON THE TIP OF THE SELF EXPANDING STENT SYSTEM (SESS) DURING REMOVAL OF THE TIP MANDREL, INSUFFICIENT SUPPORT DURING PREP, KINKS IN THE SHAFT, INTERACTION DURING LOADING ONTO A GUIDE WIRE, OR INTERACTIONS WITH THE INTRODUCER SHEATH AND/OR ASSOCIATED DEVICES DURING INSERTION. TO ENSURE THIS IS NOT RESULT OF A MANUFACTURING DEFICIENCY, ALL SHEATHED STENTS ARE VISUALLY INSPECTED FOR STENT LOCATION BETWEEN THE MARKERS AND THAT THE STENT IS FULLY COVERED WITHIN THE DISTAL SHEATH. ADDITIONALLY, ALL SHAFTS ARE VISUALLY INSPECTED FOR DAMAGE/KINKS. IN THIS CASE, IT MAY BE POSSIBLE THAT THE TIP OF THE ABSOLUTE PRO WAS INADVERTENTLY PULLED DURING REMOVAL OF THE TIP MANDREL CAUSING THE STENT TO EXPOSE. WITHOUT THE RETURN OF THE DEVICE TO EXAMINE, A CONCLUSIVE CAUSE FOR THE REPORTED PREMATURE DEPLOYMENT COULD NOT BE DETERMINED. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS FOR THIS LOT AND THERE HAVE BEEN NO OTHER INCIDENTS REPORTED FOR THIS LOT. ADDITIONALLY, THE LOT RELEASE TESTING RESULTS WERE REVIEWED AND THIS LOT MET ALL RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING UNPACKAGING OF THE ABSOLUTE PRO STENT SYSTEM, IT WAS NOTED THAT THE STENT WAS PARTIALLY DEPLOYED. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. ANOTHER SAME DEVICE WAS USED TO TREAT THE TARGET LESION. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THOUGH REQUESTED, 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 9060551

    Patients

    Seq Age Sex Outcome Treatment
    1