BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABSOLUTE PRO .035 SELF EXPANDING STENT SYSTEM

    MDR report key: 2160035 · Received July 13, 2011

    Report

    Report Number
    2024168-2011-04940
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    June 16, 2011
    Report Date
    June 16, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    FGE
    PMA / PMN Number
    K072708
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INVESTIGATION OF THE DEVICE INDICATES NO RELEVANT DAMAGE AND THAT NO DEPLOYMENT HAD BEEN ATTEMPTED, THERE IS NO INDICATION OF A FUNCTIONAL TRIGGER FOR THE STENT EXITING THE DISTAL SHEATH. SUCH OCCURRENCES ARE REPLICATED WHEN THE TIP OF THE CATHETER IS PULLED RATHER THAN THE STYLET (TIP MANDREL). THIS IS HIGHLIGHTED IN THE INSTRUCTIONS FOR USE, HOLDING THE TIP MANDREL IN PLACE, INJECT SALINE INTO THE LUMEN THROUGH THE PROXIMAL LUER FITTING AT THE END OF THE HOUSING ASSEMBLY. FLUSH UNTIL FLUID IS OBSERVED EXITING AT THE END OF THE SHEATH NEAR THE DISTAL END OF THE STENT. HOLD THE DISTAL TIP OF THE DELIVERY SYSTEM. DO NOT HOLD THE STENT AREA. GENTLY TWIST AND PULL TO REMOVE THE TIP MANDREL. IF THE TIP MANDREL IS NOT EASILY REMOVED, DO NOT USE THE DEVICE. BASED ON THE UPDATED INVESTIGATION FINDINGS, THE BENDS IN THE STYLET AND CATHETER APPEAR TO BE DUE TO POST-PROCEDURAL HANDLING AND NOT A CAUSE FOR THE PREMATURE DEPLOYMENT.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED SELF EXPANDING STENT SYSTEM (SESS) FOUND BLOOD AND SALINE IN THE GUIDE WIRE LUMEN, CONSISTENT WITH BEING ADVANCED ONTO A GUIDE WIRE. THE STENT IMPLANT WAS STATIONARY ON THE SHAFT AND PARTIALLY DEPLOYED 1CM OVER THE TIP. THERE WAS NO DAMAGE NOTED TO THE STENT IMPLANT. THE DISTAL SHEATH WAS IN THE DISTAL POSITION AND NOT RETRACTED. THERE WERE TWO BENDS IN THE SHAFT 42 CM AND 107CM DISTAL TO THE STRAIN RELIEF TUBING. THERE WAS NO OTHER DAMAGE NOTED TO THE SESS. THE HANDLE LOCK WAS IN THE LOCKED POSITION. THE STYLET WAS RETURNED FULLY ADVANCED THROUGH THE TIP AND GUIDE WIRE LUMEN. DURING FUNCTIONAL TESTING, AN ATTEMPT WAS MADE TO REMOVE THE STYLET BUT THE STYLET WAS FROZEN IN THE GUIDE WIRE LUMEN. AFTER THE SESS WAS SOAKED IN THE WATER BATH, THE STYLET WAS REMOVED FROM THE SESS WITH RESISTANCE AT THE TWO BENDS IN THE SHAFT. THERE WERE TWO BENDS IN THE STYLET AT THE SAME LOCATION AS THE BENDS IN THE SHAFT 42CM AND 107CM DISTAL TO THE STRAIN RELIEF TUBING. THERE WAS NO THERE DAMAGE NOTED TO THE SESS. AFTER OPENING THE HANDLE, OBSERVED THE RACK WAS IN THE DISTAL POSITION AND NOT RETRACTED. THERE WAS NO DAMAGE NOTED TO THE INTERNAL MECHANISMS. 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 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 IS POSSIBLE THAT THE KINKS IN SHAFT AND STYLET CAUSED RESISTANCE WITH THE INNER MEMBER DURING REMOVAL OF THE TIP MANDREL. THIS RESISTANCE DUE TO THE LINKS MAY HAVE CAUSED THE STENT TO PULL OUT OF FROM THE STENT HOLDER DURING REMOVAL OF THE MANDREL. ALTHOUGH THE SOURCE OF THE KINKS COULD NOT BE DETERMINED, KINKS MAY BE THE RESULT OF HANDLING OR INSUFFICIENT SUPPORT OF THE SHAFT DURING REMOVAL FROM THE PACKAGING. 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, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO OTHER INCIDENTS REPORTED FOR THIS LOT. A CONCLUSIVE CAUSE FOR THE KINKS AND PREMATURE DEPLOYMENT COULD NOT BE DETERMINED; HOWEVER, THERE IS NO INDICATION TO SUGGEST A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE ABSOLUTE PRO STENT DELIVERY SYSTEM WAS REMOVED FROM THE PACKAGING, THE DEVICE WAS IN A LOCKED CONDITION AND THE STENT WAS PARTIALLY DEPLOYED WITH A COUPLE OF ROWS OUT OF THE PROTECTIVE SHEATH. THE DEVICE WAS NOT USED. ANOTHER ABSOLUTE PRO WAS USED TO FINISH THE PROCEDURE; IT WAS IMPLANTED SUCCESSFULLY AND WITHOUT ADVERSE CONSEQUENCES. THERE WAS NO PATIENT INVOLVEMENT. 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 1022461

    Patients

    Seq Age Sex Outcome Treatment
    1