BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPERT SELF-EXPANDING TRANSHEPATIC STENT SYSTEM

    MDR report key: 3984594 · Received August 6, 2014

    Report

    Report Number
    2024168-2014-04962
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    July 11, 2014
    Report Date
    July 15, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    FGE
    PMA / PMN Number
    K050534
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE DEPLOYMENT ISSUE COULD NOT BE CONFIRMED DUE TO THE CONDITION OF THE RETURNED DEVICE. THE SEPARATION WAS CONFIRMED. BASED ON A VISUAL INSPECTION OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. THE LOT HISTORY RECORD (LHR) FOR THIS PRODUCT COULD NOT BE REVIEWED AND A SIMILAR INCIDENT QUERY COULD NOT BE PERFORMED BECAUSE THE LOT NUMBER WAS NOT REPORTED AND THE PACKAGING WAS NOT RETURNED. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN LESION LOCATED IN AN UNDETERMINED ARTERY. THE 6X40 XPERT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED; HOWEVER, THE SHAFT BENT. THE DEVICE WAS RETRACTED FROM THE PATIENT AND A 6X30 XPERT SDS WAS ADVANCED. DURING THE ATTEMPT TO DEPLOY THE STENT, THE DEVICE BROKE AT THE METAL SHAFT. ANOTHER SDS WAS USED TO SUCCESSFULLY TREAT THE LESION. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459142 XPERT SELF-EXPANDING TRANSHEPATIC STENT SYSTEM SELF-EXPANDING STENT AND DELIVERY SYSTEM FGE AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1