BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 891400 · Received August 7, 2007

    Report

    Report Number
    3004742046-2007-00247
    Event Type
    Injury
    Date Received
    August 7, 2007
    Date of Event
    July 11, 2007
    Report Date
    July 13, 2007
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    NIM
    PMA / PMN Number
    P040012
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD IS FORTHCOMING. A FOLLOW-UP WILL BE SUBMITTED WITH ANY RELEVANT INFORMATION. THE RX ACCUNET PART # 1011649-65, LOT # 5090651.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: NONE. SYMPTOMS/AE: TIA/STROKE. TIME OF SYMPTOMS/AE: PRE-PROCEDURE/POST-PROCEDURE. IT WAS REPORTED THAT THE PATIENT HAD A LEFT INTERNAL CAROTID ARTERY STENTING PROCEDURE IN 2007. THE PATIENT EXPERIENCED A TRANSIENT ISCHEMIC ATTACK, TIME OF THE EVENT NOT REPORTED. THE PATIENT RECEIVED UNSPECIFIED THROMBOLYTIC, VASOPRESSORS AND INOTROPIC THERAPY AND REPORTEDLY THE CONDITION IMPROVED. THE NEXT DAY, THE PATIENT EXPERIENCED A STROKE, SYMPTOMS UNSPECIFIED. THE PATIENT CONTINUED TO RECEIVE THROMBOLYTIC TREATMENT, VASOPRESSORS/INOTROPES AND WAS INTUBATED WITH VENTILATOR SUPPORT. THE PATIENT WAS DISCHARGED FIFTEEN DAYS LATER TO A REHABILITATION FACILITY, WITH THEIR CONDITION REPORTED AS "CONTINUING". THOUGH REQUESTED, NO ADDITIONAL INFORMATION AVAILABLE. STUDY EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ACCULINK CAROTID STENT SYSTEM NIM ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 7030751

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization| L| R| S RX ACCUNET