BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABSOLUTE PRO .035 SELF EXPANDING STENT SYSTEM

    MDR report key: 1961580 · Received January 14, 2011

    Report

    Report Number
    2024168-2011-00295
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 13, 2010
    Report Date
    December 20, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    FGE
    PMA / PMN Number
    K072708
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: ADDED. CONCLUSIONS: ADDED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SELF EXPANDING STENT SYSTEM (SESS) WAS RETURNED WITH BLOOD ON THE HANDLE AND NO SALINE VISIBLE, CONSISTENT WITH HANDLING DURING PREPARATION OF THE DEVICE. THE STENT IMPLANT WAS PARTIALLY EXPANDED DISTALLY FROM THE DISTAL OUTER SHEATH FOR A LENGTH OF 1.1 CM (WITH FOUR ROWS OF THE DISTAL END OF THE STENT PARTIALLY EXPANDED). THE PROXIMAL END OF THE STENT WAS MISLOCATED ON THE STENT HOLDER 1.7 CM DISTAL TO THE PROXIMAL MARKER BAND. THE DISTAL OUTER SHEATH WAS NOT RETRACTED, THE HANDLE WAS IN THE LOCKED POSITION AND THE RACK WAS IN THE DISTAL POSITION; WHICH IS CONSISTENT WITH NO ATTEMPT AT DEPLOYMENT VIA THE THUMBWHEEL. A KINK WAS NOTED IN THE DISTAL OUTER SHEATH, CONSISTENT WITH HANDLING. THERE WAS NO FURTHER DAMAGE NOTED ON THE SESS AND NO ANOMALIES NOTED IN THE MECHANISMS WITHIN THE HANDLE. THE TYVEK POUCH AND COIL DISPENSER WERE RETURNED WITH THIS DEVICE. 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/RESISTANCE 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 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. THE MISLOCATION OF THE STENT MAY HAVE BEEN DUE TO, AMONG OTHER THINGS, SUBSEQUENT HANDLING OF THE SESS AFTER THE INITIAL PREMATURE, PARTIAL DEPLOYMENT OR THE KINK IN THE DISTAL SHEATH PUSHING THE STENT DISTALLY, BUT A CONCLUSIVE CAUSE CAN 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 FOR PREMATURE DEPLOYMENT REPORTED FOR THIS LOT. A CONCLUSIVE CAUSE FOR THE 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 DURING DEVICE PREPARATION THE STENT DEPLOYED WHEN THE PACKAGE WAS OPENED. THERE WAS NO PATIENT INVOLVEMENT. 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 0080351

    Patients

    Seq Age Sex Outcome Treatment
    1