BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 836109 · Received April 6, 2007

    Report

    Report Number
    3004742046-2007-00114
    Event Type
    Injury
    Date Received
    April 6, 2007
    Date of Event
    March 13, 2007
    Report Date
    March 19, 2007
    Manufacturer
    GUIDANT ENDOVASCULAR SOLUTIONS
    Product Code
    NIM
    PMA / PMN Number
    P040012
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORD (LHR) DID NOT REVEAL ANY NON-CONFORMITIES WHICH COULD HAVE CONTRIBUTED TO THIS COMPLAINT. THE RX ACCUNET PART# 1011649-55, LOT# 6071251, REFERENCED IN B5 AND D11 IS BEING REPORTED UNDER MANUFACTURER REPORT NUMBER 3004742046-2007-00113.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: NONE. TIME OF SYMPTOMS/AE: DURING THE PROCEDURE. SYMPTOMS/AE: EMBOLIC EVENT/STROKE. IT WAS REPORTED THAT DURING A LICA STENTING, THE PROCEDURE WAS COMPLICATED BY AN EMBOLIC EVENT (STROKE) TO THE M2 DIVISION OF THE LMCA CORRESPONDING TO SEVERE NEUROLOGIC DEFICIT. THIS WAS TREATED WITH A TOTAL OF 18MG T-PA (THROMBOLYTIC TREATMENT) INFUSED INTO THE THROMBUS RESULTING IN COMPLETE RECANALIZATION OF THE VESSEL. THIS WAS NOTED AS RESOLVED IN 2007, AND THE PATIENT WAS DISCHARGED TO HOME THAT SAME DAY. NO ADDITIONAL INFORMATION AVAILABLE. STUDY EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ACCULINK CAROTID STENT SYSTEM NIM NIM GUIDANT ENDOVASCULAR SOLUTIONS NA 6120651

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention| S RX ACCUNET| T-PA| HEPARIN