BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPIDERX EMBOLIC PROTECTION DEVICE

    MDR report key: 1671713 · Received April 29, 2010

    Report

    Report Number
    2183870-2010-00067
    Event Type
    Death
    Date Received
    April 29, 2010
    Date of Event
    March 13, 2008
    Report Date
    April 2, 2010
    Manufacturer
    EV3 INC.
    Product Code
    NTE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS DEVICE DID NOT REVEAL ANY DISCREPANCIES RELEVANT TO THIS REPORTED EVENT.

    Description of Event or Problem · 1

    THIS PROCEDURE WAS PERFORMED IN (B) (6). THE SPIDERX WAS DELIVERED OVER A LESION ABOUT 4CM LONG. THE PHYSICIAN THEN DELIVERED A BALLOON BY THE SPIDERX FILTER WIRE, AND RETRIEVED THE BALLOON AFTER INFLATION. THE PHYSICIAN THEN DELIVERED AN 8X40 STENT, AND USED THE RETRIEVAL CATHETER TO REMOVE THE SPIDERX. AT THIS POINT THE PHYSICIAN FOUND THE SPIDERX COULD NOT MOVE. THE SPIDERX WIRE WAS WITHIN THE STENT, SO THE PHYSICIAN A CATHETER TO RETRIEVE THE DEVICE BUT FAILED. THE PT WAS TRANSFERRED TO (B) (6) HOSPITAL FOR SURGERY. DURING SURGERY THROMBUS BY THE SPIDERX WAS NOTED, BUT THE VESSEL WAS FINE. THE FILTER WIRE WAS CUT BUT THE PHYSICIAN DID NOT REMOVE THE SPIDERX. THE PT WAS FINE AFTER SURGERY, HOWEVER, TWO DAYS LATER, THE PT WAS NOTED TO HAVE POOR RESPIRATION AND MULTI ORGAN EXHAUSTION. THE PT EXPIRED TWO DAYS AFTER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPIDERX EMBOLIC PROTECTION DEVICE NTE EV3 INC. SPDRX050 2861060

    Patients

    Seq Age Sex Outcome Treatment
    1 Death