BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABSOLUTE PRO .035 SELF EXPANDING STENT SYSTEM

    MDR report key: 2022485 · Received March 17, 2011

    Report

    Report Number
    2024168-2011-01792
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 18, 2011
    Report Date
    February 21, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    FGE
    PMA / PMN Number
    K072708
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. THE SELF EXPANDING STENT SYSTEM (SESS) WAS RETURNED WITHOUT BLOOD VISIBLE, CONSISTENT WITH THE REPORTED INFORMATION THAT THERE WAS NO PATIENT INVOLVEMENT. THERE WAS SALINE ON THE SHAFT. THE STENT IMPLANT HAD BEEN FULLY DEPLOYED AND WAS NOT RETURNED, CONSISTENT WITH THE REPORTED INFORMATION THAT THE STENT WAS PURPOSELY MANIPULATED ON THE STENT DELIVERY SYSTEM AND COMPLETELY EXPANDED. THE SHEATH WAS PARTIALLY RETRACTED. THE DISTAL END OF THE DISTAL OUTER SHEATH WAS LOCATED 3.7CM PROXIMAL TO THE PROXIMAL MARKER, INDICATING THAT THE THUMBWHEEL HAD BEEN ROTATED. THERE WAS NO OTHER DAMAGE NOTED TO THE SESS. THE HANDLE WAS IN THE LOCKED POSITION. THE STYLET WAS RETURNED INSERTED THROUGH THE TIP. DURING FUNCTIONAL TESTING, THE HANDLE OF THE SESS WAS OPENED TO REVEAL THAT THE RACK WAS ALSO PARTIALLY RETRACTED, FURTHER SUGGESTING THAT THE THUMBWHEEL MAY HAVE BEEN PARTIALLY ROTATED. POTENTIAL FACTORS WHICH COULD CONTRIBUTE PREMATURE DEPLOYMENT PRIOR TO USE INCLUDE, BUT ARE NOT LIMITED TO, MANUFACTURING, INADVERTENTLY PULLING ON THE TIP OF THE 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, THE PREMATURE DEPLOYMENT APPEARS TO BE RELATED TO THE RESISTANCE ENCOUNTERED DURING REMOVAL OF THE TIP MANDREL. HOWEVER, A DEFINITIVE CAUSE FOR THE RESISTANCE COULD NOT BE DETERMINED AS THERE WAS NO RESISTANCE NOTED WITH THE TIP MANDREL ON THE RETURNED PRODUCT. THERE IS NO INDICATION TO SUGGEST A PRODUCT QUALITY DEFICIENCY. REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS FOR THIS LOT THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. ADDITIONALLY, THE LOT RELEASE TESTING RESULTS WERE REVIEWED AND THIS LOT MET ALL RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED DIFFICULTY REMOVING THE STYLET IS CONSISTENT WITH INADVERTENT GRASPING OF THE TIP WHILE REMOVING THE STYLET. THE ABSOLUTE INSTRUCTIONS FOR USE STATES: 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING DEVICE PREPARATION THE STYLET WAS DIFFICULT TO REMOVE FROM THE NOSE CONE OF THE STENT DELIVERY SYSTEM. AFTER IT WAS PULLED AGGRESSIVELY THE STYLET CAME OUT AND THE STENT PARTIALLY DEPLOYED. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. AFTERWARDS THE STENT WAS PURPOSEFULLY MANIPULATED ON THE DELIVERY SYSTEM AND THE STENT COMPLETELY EXPANDED. 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 0050451

    Patients

    Seq Age Sex Outcome Treatment
    1