BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPERT SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM

    MDR report key: 2200402 · Received August 11, 2011

    Report

    Report Number
    2024168-2011-05667
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    May 15, 2011
    Report Date
    July 18, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    FGE
    PMA / PMN Number
    K050534
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. POTENTIAL FACTORS THAT COULD CONTRIBUTE TO 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. THE DATE OF OCCURRENCE WAS REPORTED AS (B)(6) 2011. IN REVIEW OF THE PRODUCT LABEL ATTACHED TO THE LOT HISTORY RECORD, IT WAS NOTED THAT THE PRODUCT EXPIRATION DATE WAS (B)(4) 2011. ALTHOUGH, THE PRODUCT WAS NOT USED IN THE PATIENT, THE XPERT INSTRUCTION FOR USE STATES: USE PRIOR TO THE USE BY DATE. THE PRODUCT BEING EXPIRED BY 15 DAYS DOES NOT APPEAR TO HAVE CONTRIBUTED TO THE REPORTED PREMATURE DEPLOYMENT. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS FOR THIS LOT. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED 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. 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 DEVICE UNPACKING, THE STENT WAS NOTED TO BE EXPOSED WITH THE SHEATH SLIGHTLY RETRACTED. THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XPERT SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM SELF-EXPANDING STENT AND DELIVERY SYSTEM FGE AV-TEMECULA-CT 598212

    Patients

    Seq Age Sex Outcome Treatment
    1