BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPIDERX EMBOLIC PROTECTION DEVICE

    MDR report key: 718972 · Received May 18, 2006

    Report

    Report Number
    2183870-2006-00022
    Event Type
    Malfunction
    Date Received
    May 18, 2006
    Date of Event
    April 18, 2006
    Report Date
    April 21, 2006
    Manufacturer
    EV3 INC.
    Product Code
    NTE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    MD MENTIONED DIFFICULTY DEPLOYING 6.0MM FILTER THROUGH DELIVERY CATHETER. FILTER DEPLOYED APPROXIMATELY 4-5CM DISTAL TO LESION. SUCCESSFUL STENTING PERFORMED. UNSUCCESSFUL ATTEMPTS TO RECOVER FILTER WITH RECOVERY END OF CATHETER. FILTER WOULD NOT RETRIEVE. GUIDE SHEATH WAS PUSHED INTO STENTED CAROTID FOR MORE SUPPORT, THIS WAS STILL UNSUCCESSFUL. PHYSICIAN THEN ADVANCED THE GUIDE SHEATH; THIS WAS PUT INTO THE STENT JUST TO THE DISTAL SEGMENT OF THE STENT. PHYSICIAN THEN PULLED THE MICROCATHETER, THE RECOVERY CATHETER AND CAPTURE WIRE OUT SUCCESSFULLY. NO PATIENT INJURY OR MEDICAL/SURGICAL INTERVENTION REQUIRED. PATIENT IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPIDERX EMBOLIC PROTECTION DEVICE NTE NTE EV3 INC. SPDRX-US-060 1396622

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN