BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM STANDARD

    MDR report key: 7435712 · Received April 17, 2018

    Report

    Report Number
    2183870-2018-00233
    Event Type
    Injury
    Date Received
    April 17, 2018
    Date of Event
    January 16, 2017
    Report Date
    April 17, 2018
    Manufacturer
    COVIDIEN
    Product Code
    FGE
    PMA / PMN Number
    K060057
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE/DATE OF BIRTH: MEAN AGE. SEX: MAJORITY GENDER. DATE OF EVENT: ESTIMATE BASED ON DATE OF PUBLICATION OF ARTICLE. LIVER TRANSPLANTATION 23 1133¿1142 2017 AASLD. DOI: 10.1002/LT.24737 RECEIVED OCTOBER 20, 2016; ACCEPTED (B)(6) 2017. SAFETY AND EFFICACY OF TRANSHEPATIC AND TRANSSPLENIC ACCESS FOR ENDOVASCULAR MANAGEMENT OF PORTAL VEIN COMPLICATIONS AFTER LIVER TRANSPLANTATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    EIGHTEEN (18) PATIENTS WITH WERE TREATED WITH PROTÉGÉ EVERFLEX, COOK SHEATH AND NON-MEDTRONIC DEVICES, 12 PATIENTS UNDERWENT STENT PLACEMENT IN THE MAIN PORTAL VEIN TO THE PROXIMAL RIGHT PORTAL VEIN ACROSS THE PORTAL VEIN ANATOMOTIC STENOSIS, THE PROXIMAL SUPERIOR MESENTERIC VEIN AND SPLENIC VEIN. IT WAS REPORTED ALL THE PATIENTS ENCOUNTERED FLANK PAIN TREATED WITH ANALGESICS. ONE (1) PATIENT SUFFERED RESTENOSIS WITH PARTIAL THROMBOSIS AT THE 3-MONTH FOLLOW-UP CT SCAN, THIS PATIENT WAS TREATED WITH BALLOON ANGIOPLASTY AND FURTHER STENTING. HOWEVER, MELENA RECURRED 6 MONTHS LATER CT AND DIRECT PORTAL VEIN VENOGRAPHY REVEALED EXTENSIVE IN-STENT THROMBOSIS. THROMBOLYSIS AND BALLOON ANGIOPLASTY WERE PERFORMED. FLOW WAS NOT RESTORED; THE PATIENT IS UNDERGOING CONSERVATIVE MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278761 PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM STANDARD CATHETER, BILIARY, DIAGNOSTIC FGE COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention