BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABSOLUTE PRO .035 SELF EXPANDING STENT SYSTEM

    MDR report key: 2111525 · Received June 2, 2011

    Report

    Report Number
    2024168-2011-03834
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    May 10, 2011
    Report Date
    May 10, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    FGE
    PMA / PMN Number
    K072708
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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. EVALUATION SUMMARY: THE SELF EXPANDING STENT SYSTEM (SESS) WAS RETURNED WITH BLOOD ON THE HANDLE, CONSISTENT WITH HANDLING. THERE WAS SALINE IN THE DISTAL SHEATH. THE STENT IMPLANT WAS PARTIALLY DEPLOYED 2 CM OVER THE TIP AS REPORTED. THERE WAS NO DAMAGE NOTED TO THE STENT IMPLANT. THE DISTAL SHEATH WAS IN THE DISTAL POSITION AND NOT RETRACTED. THERE WAS NO OTHER DAMAGE NOTED TO THE SES. THE HANDLE LOCK WAS IN THE LOCKED POSITION. THE HANDLE WAS OPENED AND THE RACK WAS IN THE DISTAL POSITION AND NOT RETRACTED. ALL THE INTERNAL MECHANISMS WERE INTACT WITH NO DAMAGE NOTED. 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 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. IN THIS CASE, A CONCLUSIVE CAUSE FOR THE PREMATURE DEPLOYMENT COULD NOT BE DETERMINED; HOWEVER, IT MAY BE POSSIBLE THAT THE TIP WAS INADVERTENTLY GRASPED DURING REMOVAL OF THE TIP MANDREL CAUSING THE STENT TO PARTIALLY DEPLOY FROM THE DISTAL OUTER SHEATH. THE TIP MANDREL WAS NOT RETURNED, INDICATING THAT IT HAD BEEN REMOVED. A CONCLUSIVE CAUSE FOR THE PREMATURE DEPLOYMENT COULD NOT BE DETERMINED; HOWEVER, THERE IS NO INDICATION TO SUGGEST A PRODUCT DEFICIENCY. 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. DURING PRODUCTION ALL SHEATHED STENTS ARE VISUALLY INSPECTED FOR STENT LOCATION BETWEEN THE MARKERS AND VERIFICATION THAT THE STENT IS FULLY COVERED WITHIN THE DISTAL SHEATH. PRODUCTION ALSO INSPECTS ALL SHAFTS VISUALLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION OF THE ABSOLUTE PRO, THE STENT PARTIALLY DEPLOYED ON THE TABLE. ANOTHER ABSOLUTE PRO WAS USED TO COMPLETE THE PROCECDURE SUCCESSFULLY. 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 0060951

    Patients

    Seq Age Sex Outcome Treatment
    1