BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 2073169 · Received April 29, 2011

    Report

    Report Number
    2024168-2011-03022
    Event Type
    Injury
    Date Received
    April 29, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 6, 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 EFFECTS OF CEREBROVASCULAR ACCIDENT (STROKE) AND WEAKNESS ARE LISTED IN THE PRODUCT INSTRUCTION FOR USE AS 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 ONE DAY POST STENTING PROCEDURE IN THE LEFT INTERNAL CAROTID ARTERY WITH TWO PLANNED RX ACCULINK STENTS, THE PATIENT EXPERIENCED A NEW ACUTE ONSET OF RIGHT-SIDED WEAKNESS AND WAS DIAGNOSED WITH A STROKE. THE PATIENT WAS TREATED WITH ENOXAPARIN. THE CONDITION REMAINS UNCHANGED. THE PATIENT WAS DISCHARGED ON 04/12/2011 TO A REHABILITATION FACILITY. 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 0062361

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization| R| S RX ACCULINK