BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTEGE STENT

    MDR report key: 5404957 · Received January 16, 2004

    Report

    Report Number
    2134479-2003-00008
    Event Type
    Malfunction
    Date Received
    January 16, 2004
    Date of Event
    December 4, 2003
    Report Date
    January 3, 2004
    Manufacturer
    EV3 INC
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    PRE-DILATED TRIED TO ADVANCE PROTEGE INTO A HIGHLY CALCIFIED LESION. PROTEGE WOULD NOT CROSS AND WAS REMOVED. ADDITIONAL BALLOON DILATIONS WERE PERFORMED AND PROTEGE WAS RE-INTRODUCED, HOWEVER, WOULD NOT CROSS LESION. THE STENT WOULD NOT DEPLOY. THE PROTEGE WAS THEN REMOVED WITHOUT INCIDENT. THEY PARTIALLY DEPLOYED OUTSIDE OF BODY, SO THE PHYSICIAN FELT THE PROBLEM OF DEPLOYMENT WAS DUE TO CALCIFIED LESION. A SECOND STENT WAS INTRODUCED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTEGE STENT BILIARY STENT SYSTEM FGE EV3 INC SE7-6-150-120 201143

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK