BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPERT SELF-EXPANDING STENT SYSTEM

    MDR report key: 2110724 · Received June 1, 2011

    Report

    Report Number
    2024168-2011-03823
    Event Type
    Malfunction
    Date Received
    June 1, 2011
    Date of Event
    May 11, 2011
    Report Date
    May 11, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    FGE
    PMA / PMN Number
    K050534
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    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 PREMATURE DEPLOYMENT PRIOR TO USE INCLUDE, BUT ARE NOT LIMITED TO, MANUFACTURING, HANDLING, INSUFFICIENT SUPPORT DURING PREP, KINKS IN THE SHAFT, LOOSENING OF THE TUOHY BORST VALVE, 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 SELF EXPANDING STENT DELIVERY SYSTEMS ARE INSPECTED FOR DAMAGE DURING THE MANUFACTURING PROCESS. 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. WITHOUT HAVING THE DEVICE TO EXAMINE, A CONCLUSIVE CAUSE 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 PREPARATION OF THE XPERT STENT WITH SALINE WATER, THE PART OF THE STENT NEAR THE TIP OF THE DELIVERY DEVICE OPENED 5MM. THE DEVICE WAS NOT USED IN THE PATIENT AND THERE WAS NO PATIENT INVOLVEMENT. ANOTHER UNKNOWN DEVICE WAS USED TO COMPLETE THE PROCEDURE. THOUGH REQUESTED, THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XPERT SELF-EXPANDING STENT SYSTEM SELF-EXPANDING STENT AND DELIVERY SYSTEM FGE AV-TEMECULA-CT 700704

    Patients

    Seq Age Sex Outcome Treatment
    1