BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 1969572 · Received January 24, 2011

    Report

    Report Number
    2024168-2011-00440
    Event Type
    Injury
    Date Received
    January 24, 2011
    Date of Event
    December 16, 2010
    Report Date
    December 30, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. BIVALIRUDIN. EMBOLIC PROTECTION: RX ACCUNET ((B)(4), LOT # 0102761) STROKE AND SEIZURE MAY OCCUR DURING THIS TYPE OF PROCEDURE AND AS LISTED IN THE INSTRUCTIONS FOR USE, STROKE AND SEIZURE ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE USE OF THE PRODUCT. THE REPORTED HOSPITALIZATION AND MEDICATION WERE IN RESPONSE TO THE PATIENT SYMPTOMS. THERE WAS NO DEVICE MALFUNCTION REPORTED THAT COULD HAVE CONTRIBUTED TO THE EVENT. INFORMATION AVAILABLE IN THE CASE DESCRIPTION IS NOT SUFFICIENT TO DETERMINE A RELATIONSHIP BETWEEN THE EVENT AND THE ABBOTT VASCULAR PRODUCT. BASED ON AVAILABLE INFORMATION, A DEFINITIVE CAUSE FOR THE REPORTED PATIENT ADVERSE EFFECTS AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED, HOWEVER, THERE WAS NO INDICATION OF ANY PRODUCT DEFICIENCIES WHICH COULD HAVE CONTRIBUTED TO THE OUTCOME OF THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A TRIAL THAT AFTER THE IMPLANTATION OF THE ACCULINK STENT IN THE RIGHT INTERNAL CAROTID ARTERY, THE PATIENT EXPERIENCED A RIGHT MAIN CEREBRAL ARTERY INFARCT WITH MINOR WEAKNESS IN THE LEFT UPPER EXTREMITY. THIS EVENT WAS ACCOMPANIED BY ALCOHOL WITHDRAWAL AND SEIZURES. THE PATIENT WAS GIVEN SUPPORTIVE CARE, INCLUDING MEDICATION WITH ATIVAN AND AMIODARONE, FOR SEVEN DAYS AND THEN TRANSFERRED TO REHABILITATION. THE PATIENT'S CONDITION HAS IMPROVED, BUT IS CONTINUING. 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 0052061

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R| S