BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARAMOUNT MINI GPS

    MDR report key: 509052 · Received January 9, 2004

    Report

    Report Number
    2134479-2003-00010
    Event Type
    Malfunction
    Date Received
    January 9, 2004
    Date of Event
    December 8, 2003
    Report Date
    December 26, 2003
    Manufacturer
    EV3 INC
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN ENGAGED OSTIUM OF THE RENAL ARTERY. CROSSED LESION WITH CHOICE PT GUIDEWIRE, PREDILATED LESION WITH A 4XS SYMMETRY BALLOON @ 12 ATMS. REMOVED BALLOON AND ADVANCED STENT THROUGH THE GUIDING SHEATH, THEN FURTHER ADVANCED STENT ACROSS LESION. WHEN ATTEMPTING TO REPOSITION UN-DEPLOYED STENT, STENT MIGRATED DISTALLY. PHYSICIAN MADE THE DECISION TO INFLATE STENT, AT WHICH TIME THE DISTAL END OF THE STENT DID NOT EXPAND. THE PHYSICIAN REMOVED BALLOON AND LOST WIRE ACCESS. REGAINED WIRE ACCESS WITH ANOTHER GUIDEWIRE AND THEN ADVANCED NEW BALLOON OVER GUIDEWIRE WITH INTENT OF PASSING BALLOON THROUGH UN-DEPLOYED PORTION OF THE STENT, HOWEVER, THE STENT MIGRATED FURTHER DISTALLY. AFTER CONSIDERABLE TIME OF MANIPULATION THE PHYSICIAN CHOSE TO USE ANOTHER STENT TO TREAT OSTIAL LESION. THE FIRST STENT STAYED CONICAL IN SHAPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARAMOUNT MINI GPS BILIARY STENT SYSTEM FGE EV3 INC PMB4-5-14-80 263914

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN