BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XPERT SELF-EXPANDING TRANSHEPATIC STENT SYSTEM

    MDR report key: 3923024 · Received July 9, 2014

    Report

    Report Number
    2024168-2014-04419
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    June 30, 2013
    Report Date
    May 23, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    FGE
    PMA / PMN Number
    K050534
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED PATIENT EFFECT OF THROMBOSIS IS A KNOWN OBSERVED AND POTENTIAL PATIENT EFFECT AS LISTED IN THE XPERT INSTRUCTION FOR USE (IFU). ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING. DATE OF EVENT ESTIMATED. DATE OF IMPLANT ESTIMATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A SIGNIFICANT FOCAL LESION LOCATED IN THE LEFT SUPERFICIAL FEMORAL ARTERY. A FIBROCALCIFIC PLAQUE WAS VISUALISED AT THE LESION SITE. OPTICAL COHERENCE TOMOGRAPHY (OCT) IMAGING AND PRE-DILATATION OF THE LESION WAS PERFORMED PRIOR TO STENTING WITH AND XPERT STENT. POST-DILATATION WAS PERFORMED WITH GOOD RESULTS. REPEAT OCT IMAGING SHOWED COMPLETE EXPANSION OF THE STENT WITH OPTIMAL WALL APPOSITION. A SMALL RESIDUAL THROMBUS (MICROTHROMBUS) ON THE STENT SURFACE WAS VISUALIZED. THE PATIENT WAS TREATED WITH DUAL-ANTIPLATELET THERAPY FOR 1 MONTH WITH SIGNIFICANT IMPROVEMENT IN HER SYMPTOMS DURING FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399992 XPERT SELF-EXPANDING TRANSHEPATIC STENT SYSTEM SELF-EXPANDING STENT AND DELIVERY SYSTEM FGE AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention SHEATH: 6 FR CROSSOVER