BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JOSTENT ENDOSCOPIC STENT

    MDR report key: 2233240 · Received September 2, 2011

    Report

    Report Number
    2024168-2011-06129
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    July 29, 2011
    Report Date
    July 29, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    FGE
    PMA / PMN Number
    K050534
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED JOSTENT SELF EXPANDING STENT SYSTEM (SESS) NOTED BLOOD AND SALINE ON THE STENT IMPLANT. THERE WAS SALINE IN THE SHAFT. THE STENT IMPLANT WAS PARTIALLY DEPLOYED 1 CM OVER THE TIP. THERE WAS NO DAMAGE NOTED TO THE STENT IMPLANT. THE SHEATH WAS NOT RETRACTED. THERE WAS A BEND IN THE PROXIMAL END OF THE TIP. THERE WERE MULTIPLE KINKS IN THE SHEATH EQUALLY SPACED FOR A LENGTH OF 15 CM PROXIMAL TO THE DISTAL END OF THE SHEATH. THERE WAS A CURVED BEND IN THE DISTAL END OF THE SHAFT. THE TUOHY BORST VALVE WAS RETURNED UNSCREWED FROM THE TUOHY BORST ADAPTER. THERE WAS NO OTHER DAMAGE NOTED TO THE SESS. AFTER THE TUOHY BORST VALVE WAS SCREWED ONTO THE TUOHY BORST ADAPTER, THE TUOHY BORST VALVE AND SHEATH WERE RETRACTED AND THE STENT IMPLANT WAS DEPLOYED WITH NO RESISTANCE NOTED. POTENTIAL FACTORS WHICH COULD CONTRIBUTE TO DEPLOYMENT DIFFICULTY INCLUDE, BUT ARE NOT LIMITED TO, MANUFACTURING, ANATOMICAL CONDITIONS, KINKS IN THE SHAFT OR THE DISTAL END OF THE SYSTEM BEING ENTRAPPED. IN THIS CASE, IT IS LIKELY THAT THE MULTIPLE KINKS NOTED THROUGHOUT THE SHAFT CONTRIBUTED TO THE DIFFICULTY DEPLOYING. THESE TYPES OF KINKS (EQUALLY SPACED) ARE TYPICALLY THE RESULT OF THE SHAFT BEING OVER BENT IN THE ANATOMY DURING ADVANCEMENT. THE ANATOMY WAS REPORTED AS MILDLY TORTUOUS WHICH MAY HAVE CONTRIBUTED TO THE KINKS. THE PARTIAL STENT DEPLOYMENT IS LIKELY DUE TO THE ATTEMPT TO RETRACT THE DISTAL OUTER SHEATH CAUSED THE STENT TO PARTIALLY DEPLOY 1 CM. THE TUOHY BORST VALVE RETURNED UNSCREWED FROM THE TUOHY BORST ADAPTER LIKELY OCCURRED DURING THE ATTEMPT TO DEPLOY THE STENT. A REVIEW OF THE DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS FOR THIS LOT, INDICATING ALL LOT RELEASE TESTING MET SPECIFICATION. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO OTHER INCIDENTS REPORTED FOR THIS LOT. THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. BASED ON THE RETURNED DEVICE ANALYSIS, IT IS LIKELY THAT THE MULTIPLE KINKS IN THE SHAFT CONTRIBUTED TO THE DIFFICULTY. ALL SELF EXPANDING STENT DELIVERY SYSTEMS ARE INSPECTED FOR DAMAGE DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE OF THE BILIARY DUCT, A SELFX STENT SYSTEM WAS ADVANCED TO THE TARGET LESION AND ATTEMPTED DEPLOYMENT BY RETRACTING THE SHEATH BUT THE STENT WOULD NOT DEPLOY. THE DEVICE WAS REMOVED FROM THE ANATOMY AND CHANGED TO A ((B)(4)) SELFX. THE STENT WAS DEPLOYED SUCCESSFULLY, HOWEVER IT DID NOT COVER THE LESION DUE TO THE LESION LENGTH. THUS A THIRD SELFX STENT ((B)(4)) WAS DEPLOYED TO FULLY COVER THE LESION. THE TARGET LESION WAS COVERED WITH TWO STENTS OF (B)(4). THE PROCEDURE WAS COMPLETED WITHOUT ISSUE. DEVICE ANALYSIS REVEALED THE STENT IMPLANT WAS PARTIALLY DEPLOYED OVER THE TIP; THE SHEATH WAS NOT RETRACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JOSTENT ENDOSCOPIC STENT SELF-EXPANDING STENT SYSTEM FGE AV-TEMECULA-CT 608700

    Patients

    Seq Age Sex Outcome Treatment
    1