BEUDAMED
    FDA Adverse Event Death Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 2111943 · Received June 2, 2011

    Report

    Report Number
    2024168-2011-03851
    Event Type
    Death
    Date Received
    June 2, 2011
    Date of Event
    April 23, 2011
    Report Date
    May 10, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECT OF DEATH IS LISTED IN THE PRODUCT INSTRUCTION FOR USE AS A KNOWN POTENTIAL ADVERSE EFFECT. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED; THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THREE DAYS POST UNEVENTFUL RX ACCULINK STENTING PROCEDURE IN THE LEFT INTERNAL CAROTID ARTERY, THE PATIENT DIED. THE PATIENT WAS FOUND UNRESPONSIVE ON THE BED IN HER HOME. THE DEATH CERTIFICATE LISTS THE CAUSES OF DEATH AS CORONARY ARTERY DISEASE AND CHRONIC OBSTRUCTIVE PULMONARY DISEASE. THOUGH REQUESTED, THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ACCULINK CAROTID STENT SYSTEM CAROTID STENT SYSTEM NIM AV-TEMECULA-CT 0102661

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death