BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROTEGE RX CAROTID STENTING SYSTEM

    MDR report key: 1013100 · Received March 14, 2008

    Report

    Report Number
    2183870-2008-00031
    Event Type
    Death
    Date Received
    March 14, 2008
    Date of Event
    February 18, 2008
    Report Date
    February 26, 2008
    Manufacturer
    EV3 INC.
    Product Code
    NIM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE REFERENCE 2183870-2008-00032 FOR THE SPIDERFX DEVICE USED IN THIS PROCEDURE.

    Description of Event or Problem · 1

    PATIENT WAS ENROLLED IN THE STUDY. PATIENT HAD PREVIOUSLY UNDERGONE CAROTID STENT PLACEMENT OF THE LEFT ICA 4 MONTHS AGO. FOLLOWING STUDY PROCEDURE ON 02/18, PATIENT NOTED TO HAVE LEFT HEMIPARESIS NOT PRESENT PRE-PROCEDURE. REVIEW OF FINAL ANGIO REVEALED BLOCKAGE OF AN M3 BRANCH OFF SUPERIOR TRUNK OF RIGHT MCA. IV INTEGRILIN STARTED-NO IMPROVEMENT NOTED. PROCEEDED WITH TRANS CATHETER TX OF THROMBOEMBOLISM-IF NOTED TO STILL BE PRESENT. IA INTEGRILIN INFUSED TO PROXIMAL SIDE OF OCCLUDED M3 BRANCH. REGION OF OCCLUSION WAS CROSSED, 2MG INTEGRILIN INJECTED DIRECTLY INTO M3 SEGMENT. PATIENTS NEURO EXAM DETERIORATED. CT DEMONSTRATED HEMORRHAGE. PATIENT TO OR FOR CRANI TO DECOMPRESS. POST CRANI PATIENT NEURO EXAM DID NOT IMPROVE ONE WEEK LATER, TREATMENT WITHDRAWN. PATIENT EXPIRED SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTEGE RX CAROTID STENTING SYSTEM NIM EV3 INC. CNSECX-8-6-40-135 2381856

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death COOK SHUTTLE SHEATH