BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTEGE RX CAROTID STENT SYSTEM

    MDR report key: 2251759 · Received September 6, 2011

    Report

    Report Number
    2251759
    Event Type
    Malfunction
    Date Received
    September 6, 2011
    Date of Event
    August 31, 2011
    Report Date
    August 31, 2011
    Manufacturer
    EV3, INC.
    Product Code
    NIM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN WAS PERFORMING A CARTOTID STENT PLACEMENT WITH ACCESS THROUGH THE RIGHT GROIN SITE. AS HE WAS REMOVING THE WIRE FROM THE CARTOTID STENT SYSTEM, THE WIRE TIP OF THE DELIVERY SYSTEM BROKE OFF INSIDE THE TOUHY AND WAS COMPLETELY CONTAINED INSIDE THE TOUHY. WE ARE NOT ABLE TO SEE EXACTLY HOW MUCH (E.G. LENGTH) OF THE DEVICE IS BROKEN OFF AND RETAINED INSIDE THE TOUHY. DUE TO THE SIZE OF THE DEVICE, WE ARE UNABLE TO DETERMINE IF THE BREAK WAS SHEARED, JAGGED, OR SMOOTH. THE TOUHY WAS OUTSIDE OF THE PATIENT. THERE WAS NO OBVIOUS DEFECT IN THE EQUIPMENT PRIOR TO USING THE DEVICE. THE PHYSICIAN SAID HE HAD NO DIFFICULTY USING THE DEVICE AND DID NOT ANTICIPATE THIS HAPPENING. HE HAS USED THIS KIND OF DEVICE PREVIOUSLY AND HAS NOT HAD THIS KIND OF EXPERIENCE. THE EVENT OCCURRED AT THE END OF THE PROCEDURE. STAFF OBTAINED ANOTHER WIRE (SAME MANUFACTURER AND LOT NUMBER) AND THE CASE WAS COMPLETED WITHOUT INCIDENT. THERE WAS NO PATIENT HARM.====================== MANUFACTURER RESPONSE FOR CAROTID STENT SYSTEM, PROTEGE RX TAPERED (PER SITE REPORTER)======================WE HAVE NOTIFIED THE MANUFACTURER AND ARE AWAITING THEIR INSTRUCTION TO RETURN THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTEGE RX CAROTID STENT SYSTEM CAROTID STENT SYSTEM NIM EV3, INC. SECX-10-7-30-135 8112195

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR NO OTHER THERAPIES