BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABSOLUTE PRO .035 SELF EXPANDING STENT SYSTEM

    MDR report key: 2193119 · Received August 5, 2011

    Report

    Report Number
    2024168-2011-05546
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 13, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    FGE
    PMA / PMN Number
    K072708
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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 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 A RESULT OF A MANUFACTURING DEFICIENCY, ALL SHEATHED STENTS ARE 100% VISUALLY INSPECTED FOR STENT LOCATION BETWEEN THE MARKERS AND THAT THE STENT IS FULLY COVERED WITHIN THE DISTAL SHEATH. ADDITIONALLY, ALL SHAFTS ARE 100% 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. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS FOR THIS LOT AND THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT DEFICIENCY. ADDITIONALLY, THE LOT RELEASE TESTING RESULTS WERE REVIEWED AND THIS LOT MET ALL RELEASE CRITERIA. WITHOUT HAVING THE PRODUCT TO EXAMINE, A CONCLUSIVE CAUSE FOR THE REPORTED PREMATURE DEPLOYMENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING DEVICE UNPACKING, THE STENT WAS PREMATURELY, PARTIALLY DEPLOYED. THE DEVICE WAS SET ASIDE AND ANOTHER ABSOLUTE PRO WAS USED SUCCESSFULLY. THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO ADDITIONAL INFORMATION 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 0060451

    Patients

    Seq Age Sex Outcome Treatment
    1