BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 2170603 · Received July 21, 2011

    Report

    Report Number
    2024168-2011-05058
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    May 15, 2011
    Report Date
    June 23, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 EFFECTS OF HEADACHE, HEMORRHAGE AND NEUROLOGICAL DEFICIT/DYSFUNCTION ARE LISTED IN THE PRODUCT INSTRUCTION FOR USE AS A KNOWN POTENTIAL ADVERSE EFFECTS ASSOCIATED WITH THE USE OF THE PRODUCT. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS 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 FOUR DAYS POST UNEVENTFUL RX ACCULINK STENTING PROCEDURE IN THE LEFT INTERNAL CAROTID ARTERY, THE PATIENT WAS HOSPITALIZED WITH A SUBARACHNOID HEMORRHAGE. SYMPTOMS INCLUDED WORD FINDING DIFFICULTY, RIGHT HAND SHAKING AND HEADACHE. CT OF THE BRAIN REVEALED SUBARACHNOID BLOOD IN THE LEFT PARIETAL LOBULE. THERE WAS NO TREATMENT GIVEN. THE PATIENT'S CONDITION RESOLVED AND THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2011. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. 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 0120361

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization