BEUDAMED
    FDA Adverse Event Other Summary report: N

    PROTEGE GPS

    MDR report key: 790552 · Received November 22, 2006

    Report

    Report Number
    2183870-2006-00061
    Event Type
    Other
    Date Received
    November 22, 2006
    Date of Event
    October 25, 2006
    Report Date
    October 25, 2006
    Manufacturer
    EV3 INC.
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    STENT WAS NOT RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    THIS PROCEDURE WAS PERFORMED IN THE RIGHT SFA. PATIENT WAS SCHEDULED FOR PERCUTANEOUS INTERVENTION OF RIGHT SFA. APPROXIMATELY 300MM LONG, DIFFUSE LESION, NO CALCIUM WAS NOTED. PHYSICIAN PRE-DILATED LESION WITH PTA BALLOON. A 6MM X 150MM PROTEGE STENT WAS FLUSHED WITH HEPARINIZED SALINE AT BOTH STANDARD LUER LOCK CONNECTION PORTS AND INSERTED INTO DISTAL SFA. DURING RETRACTION OF OUTER SHEATH RESISTANCE WAS ENCOUNTERED IN THE OUTER CATHETER DEPLOYMENT HANDLE. WHILE PHYSICIAN PULLED HANDLE THE DELIVERY CATHETER SNAPPED INTO TWO PIECES JUST DISTAL TO THE HUB. WHILE MAINTAINING WIRE POSITION, PHYSICIAN WAS ABLE TO FULLY DEPLOY STENT BY REMOVING THE OUTER STENT CATHETER AND SHEATH IN TANDEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTEGE GPS FGE FGE EV3 INC. SERP65-06-150-120 1808543

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention ARROWFLEX SHEATH| SAVVY PTA BALLOON