BEUDAMED
    FDA Adverse Event Death Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 2183120 · Received July 28, 2011

    Report

    Report Number
    2024168-2011-05379
    Event Type
    Death
    Date Received
    July 28, 2011
    Date of Event
    June 16, 2011
    Report Date
    July 5, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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 EFFECTS OF STROKE AND DEATH ARE KNOWN ADVERSE EVENTS AS LISTED IN THE INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED ADVERSE PATIENT EFFECTS AND 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 ONE DAY POST RX ACCULINK STENTING PROCEDURE IN THE RIGHT INTERNAL CAROTID ARTERY, THE PATIENT BECAME CONFUSED AND IT WAS THOUGHT THE CONFUSION WAS DUE TO A URINARY TRACT INFECTION. MRI OF THE BRAIN ON (B)(6) 2011, SHOWED MULTIPLE SMALL PUNCTATE FOCI OF ACUTE INFARCT SCATTERED THROUGHOUT THE CEREBRAL HEMISPHERE AND ALSO CEREBELLAR HEMISPHERES. THE PATIENT WAS DIAGNOSED WITH A STROKE. THERE WAS NO REPORTED TREATMENT GIVEN. THE PATIENT'S CONDITION CONTINUED, BUT WAS IMPROVED AND WAS DISCHARGED TO A REHABILITATION FACILITY FIVE DAYS AFTER THE PROCEDURE. ON (B)(4) 2011, THE PATIENT WAS HOSPITALIZED AND DIED. THE CAUSE OF DEATH IS CURRENTLY UNKNOWN. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO INITIAL MEDWATCH, ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE PATIENT EXPERIENCED A MAJOR ISCHEMIC IPSILATERAL STROKE AND EXPIRED ON (B)(6) 2011. NO ADDITIONAL INFORMATION WAS 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 1022261

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death