BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTEGE GPS SELF-EXPANDING BILIARY STENT SYSTEM 018

    MDR report key: 8235026 · Received January 10, 2019

    Report

    Report Number
    2183870-2019-00014
    Event Type
    Injury
    Date Received
    January 10, 2019
    Date of Event
    December 14, 2018
    Report Date
    July 5, 2019
    Manufacturer
    COVIDIEN
    Product Code
    FGE
    PMA / PMN Number
    K050725
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ULTRASOUND SHOWED OCCLUSION OF THE SUPERFICIAL FEMORAL VEIN STENT REMAINS 6 MONTHS POST IMPLANT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE PATIENT IS A (B)(6) FEMALE WITH A HISTORY OF VENOUS THROMBOEMBOLISM IN THE LEFT CAUDAL CFV, ONE INTO THE MID-CAUDAL EIV AND CRANIAL CFV AND ONE INTO THE CRANIAL- CAUDAL CIV AND CRANIAL EIV. APPROX 6 MONTHS POST INDEX PROCEDURE THE PATIENT SUFFERED PAIN AND EDEMA AND VENOUS OCCLUSION/ THROMBOSIS WITHIN THE STENTED SEGMENT WAS REPORTED. THE PATIENT WAS TREATED WITH MEDICATION AND A TVR WAS PERFORMED USING TWO PROTÉGÉ STENTS TO TREAT THROMBUS ASPIRATION. ULTRASOUND SHOWED VENOUS OCCLUSION/THROMBOSIS WITHIN THE PREVIOUSLY STENTED AREA AND SUPERFICIAL FEMORAL VEIN (SFV). THE EVENT IS UNRESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30465 PROTEGE GPS SELF-EXPANDING BILIARY STENT SYSTEM 018 CATHETER, BILIARY, DIAGNOSTIC FGE COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization| O