BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPERT SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM

    MDR report key: 3053426 · Received April 11, 2013

    Report

    Report Number
    2024168-2013-02201
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 19, 2013
    Report Date
    March 19, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    FGE
    PMA / PMN Number
    K050534
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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. (B)(4). THE DEVICE WAS RETURNED FOR ANALYSIS. THE PREMATURE DEPLOYMENT WAS ABLE TO BE CONFIRMED. BASED ON A VISUAL AND FUNCTIONAL INSPECTION OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. IT SHOULD BE NOTED THE XPERT STENT SYSTEM INSTRUCTIONS FOR USE STATES: ONCE THE EXPANSION OF THE STENT HAS BEGUN, THE STENT CANNOT BE RETRACTED INTO THE DELIVERY SYSTEM OR REPOSITIONED. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE PREMATURE DEPLOYMENT WAS ABLE TO BE CONFIRMED. BASED ON A VISUAL AND FUNCTIONAL INSPECTION OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. IT SHOULD BE NOTED THE XPERT STENT SYSTEM INSTRUCTIONS FOR USE STATES: INSPECT THE SYSTEM VISUALLY FOR DAMAGES THAT COULD INFLUENCE THE PERFORMANCE. INSPECT THAT THE STENT IS FULLY CONTAINED WITHIN THE OUTER TUBE. DO NOT USE IF THE STENT IS PARTIALLY DEPLOYED OR A GAP BETWEEN OUTER TUBE AND CATHETER TIP IS OVER 2MM. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    UPDATED CASE DESCRIPTION: IT WAS REPORTED THAT DURING PREPARATION OF A XPERT STENT DELIVERY SYSTEM (SDS), AFTER OPENING THE PACKAGING AND FLUSHING THE DEVICE, THERE WAS A PREMATURE PARTIAL DEPLOYMENT OF THE XPERT STENT FOUND. REPORTEDLY, THE ACCOUNT DENIED ANY MANIPULATION THAT WOULD CAUSE THE PREMATURE PARTIAL DEPLOYMENT OF THE XPERT STENT. THE ACCOUNT TRIED TO USE A SUTURE AND TIE THE TIP OF THE STENT CLOSED IN ORDER TO TRY TO REINSERT THE STENT INTO THE HEMOSTASIS VALVE OF THE SHEATH UNSUCCESSFULLY BECAUSE IT WAS THE LAST XPERT STENT AVAILABLE. THE XPERT SDS WAS NEVER ENTERED INTO THE PATIENTS ANATOMY AND WAS SET ASIDE. A NON-ABBOTT SDS WAS USED SUCCESSFULLY FOR THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT OR NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION OF A XPERT STENT DELIVERY SYSTEM (SDS), AFTER OPENING THE PACKAGING AND FLUSHING THE DEVICE, THERE WAS A PREMATURE PARTIAL DEPLOYMENT OF THE XPERT STENT FOUND. REPORTEDLY, THE ACCOUNT DENIED ANY MANIPULATION THAT WOULD CAUSE THE PREMATURE PARTIAL DEPLOYMENT OF THE XPERT STENT. THE ACCOUNT TRIED TO USE A SUTURE AND TIE THE TIP OF THE STENT CLOSED IN ORDER TO TRY TO REINSERT THE STENT INTO THE PROTECTIVE COVER UNSUCCESSFULLY BECAUSE IT WAS THE LAST XPERT STENT AVAILABLE. THE XPERT SDS WAS NEVER ENTERED INTO THE PATIENT'S ANATOMY AND WAS SET ASIDE. A NON-ABBOTT SDS WAS USED SUCCESSFULLY FOR THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT OR NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155921 XPERT SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM SELF-EXPANDING STENT AND DELIVERY SYSTEM FGE AV-TEMECULA-CT 789059

    Patients

    Seq Age Sex Outcome Treatment
    1