BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLSTENT ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM

    MDR report key: 6844948 · Received September 6, 2017

    Report

    Report Number
    2134265-2017-08720
    Event Type
    Injury
    Date Received
    September 6, 2017
    Date of Event
    September 24, 2015
    Report Date
    August 15, 2017
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K993232
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPARISON OF TECHNICAL AND CLINICAL OUTCOME OF TRANSJUGULAR PORTOSYSTEMIC SHUNT PLACEMENT BETWEEN A BARE METAL STENT AND A PTFE-STENTGRAFT DEVICE, J. LAUERMANN CARDIOVASC INTERVENT RADIOL (2016) 39:547¿556. DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE CAUSE OF THE REPORTED DIFFICULTIES COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    REPORTED VIA JOURNAL ARTICLE THAT SOME PATIENTS ENROLLED IN THE STUDY THAT RECEIVED A WALLSTENT EXPERIENCED LIVER CAPSULE PERFORATION, STENOSIS/OCCLUSION AND HEPATIC ENCEPHALOPATHY. THE AIM OF THE STUDY WAS TO REVIEW PATIENT¿S RECEIVING A TIPS (TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT) PROCEDURE. PATIENTS WERE TREATED WITH A WALLSTENT OR A POLYTETRAFUOROETHYLEN STENTGRAFT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    625526 WALLSTENT ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY UNK479

    Patients

    Seq Age Sex Outcome Treatment
    1