BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTEGE RX SELF EXPANDING NITINOL STENT

    MDR report key: 1193583 · Received September 29, 2008

    Report

    Report Number
    1193583
    Event Type
    Injury
    Date Received
    September 29, 2008
    Date of Event
    September 7, 2008
    Report Date
    September 8, 2008
    Manufacturer
    EV3 INC.
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    POOR AV FISTULA FUNCTION. DURING FISTULOGRAM, HIGH GRADE STENOSIS OF SUBCLAVIAN VEIN WAS DISCOVERED. MULTIPLE ANGIOPLASTY PROCEDURES WERE UNSUCCESSFUL. SELF EXPANDING STENT DEPLOYED AND DILATED WITH IMPROVED STENOSIS. THEN IN 2008, ECHOCARDIOGRAM DISCOVERED LARGE FOREIGN BODY, APPEARING TO BE A DISLODGED STENT, IN THE RIGHT VENTRICLE. ON TWO DAYS LATER, ANGIOGRAM CONFIRMS THE STENT LODGED IN RIGHT VENTRICLE. THERE WAS AN UNSUCCESSFUL ATTEMPT AT REMOVAL OF STENT IN INTERVENTIONAL RADIOLOGY VIA RIGHT INTERNAL JUGULAR VEIN. ON THE NEXT DAY, THE PT WAS SENT TO THE OR; THE STENT WAS SNARED AFTER MULTIPLE ATTEMPTS AND TECHNIQUES. DURING REMOVAL FROM RIGHT FEMORAL VEIN, STENT PASSED FROM VEIN INTO SUBCUTANEOUS TISSUE AND FRAGMENTED. PORTIONS REMOVED ENDOVACULARLY, REMAINING FRAGMENTS RECOVERED VIA HEMOSTAT AND SMALL GROIN INCISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTEGE RX SELF EXPANDING NITINOL STENT FGE FGE EV3 INC. SERB65-15-40-080 2603433

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention