BEUDAMED
    FDA Adverse Event Other Summary report: N

    PROTEGE EVERFLEX STENT

    MDR report key: 931852 · Received April 3, 2007

    Report

    Report Number
    2183870-2007-00025
    Event Type
    Other
    Date Received
    April 3, 2007
    Date of Event
    March 5, 2007
    Report Date
    March 5, 2007
    Manufacturer
    EV3 INC.
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A COPY OF THE CINE AND PROCEDURAL REPORT WERE SENT BACK FOR ANALYSIS. ACTUAL DEVICE WAS NOT SENT BACK.

    Description of Event or Problem · 1

    PROCEDURE: LEFT ILIAC ANGIOGRAPHY WITH RUNOFF, ANGIOPLASTY OF THE LEFT SUPERFICIAL FEMORAL ARTERY, AND STENTING OF THE LEFT SUPERFICIAL FEMORAL ARTERY. PATIENT HAD IN-STENT STENOSIS. PHYSICIAN PULLED AN EVERFLEX 150MM AND DEPLOYED IT INSIDE THE STENOSED AREA. WHEN THE 150MM STENT WAS FULLY DEPLOYED IT WAS THE SAME LENGTH AS THE 100MM STENT INSIDE THE PATIENT. THEY SUBSEQUENTLY DEPLOYED A 6X30MM STENT. FURTHER INFORMATION RECEIVED: DISTAL MARKERS ARE VISIBLE, HOWEVER, PROXIMAL MARKERS ARE QUESTIONABLE. NO PICTURES OF STENT ON DEVICE. THEY MEASURED THE 150MM STENT WITH A TAPE RULER ON THE PATIENT PRIOR TO PROCEDURE AND THE STENT MEASURES 100CM AFTER DEPLOYMENT WITHIN PREVIOUS DEPLOYED STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTEGE EVERFLEX STENT STENT FGE EV3 INC. PRB35-06-150-120 2401217

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR GLIDEWIRE| 6FR. LIMA CATHETER,| CORDIS STENT,