BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 792782 · Received December 5, 2006

    Report

    Report Number
    3004742046-2006-00506
    Event Type
    Injury
    Date Received
    December 5, 2006
    Date of Event
    October 31, 2006
    Report Date
    November 17, 2006
    Manufacturer
    GUIDANT ENDOVASCULAR SOLUTIONS
    Product Code
    NIM
    PMA / PMN Number
    P040012
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RX ACCULINK PART # 1011344-30, LOT# 6072252 REFERENCED IN B5 AND D11 IS BEING FILED UNDER THE SAME MFR REPORT NUMBER. STUDY EVENT.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: NONE. SYMPTOMS: LEFT LEG WEAKNESS, SPEECH DIFFICULTY, DYSPHASIA. TIME OF SYMPTOMS/AE: 21 DAYS POST-PROCEDURE. IT WAS REPORTED THAT THE PT RECEIVED TWO ACCULINK STENTS IN THE HEAVILY CALCIFIED RIGHT INTERNAL CAROTID IN 2006. TWENTY-ONE DAYS POST-PROCEDURE THE PT EXPERIENCED A STROKE WITH LEFT LEG WEAKNESS, SPEECH DIFFICULTY AND DYSPHASIA. THE PT WAS GIVEN HEPARIN AND COUMADIN. THE PT WAS IN INTENSIVE CARE AND THEN REHAB AND DISCHARGED TO HOME NINE DAYS LATER WITH RESIDUAL SLURRED SPEECH AND LEG WEAKNESS. REPORTEDLY, THE PT WAS REFERRED TO OUTPATIENT REHAB. NO ADD'L INFO AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ACCULINK CAROTID STENT SYSTEM NIM NIM GUIDANT ENDOVASCULAR SOLUTIONS NA 6082151

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| S OTHER: SPIDER (EPD)| RX ACCUNET| STENT: RX ACCULINK.