BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 1973229 · Received January 28, 2011

    Report

    Report Number
    2024168-2011-00534
    Event Type
    Injury
    Date Received
    January 28, 2011
    Date of Event
    May 30, 2008
    Report Date
    January 6, 2011
    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. HYPOTENSION AND NEUROLOGICAL DEFICIT/DYSFUNCTION ARE ALSO LISTED AS POTENTIAL ADVERSE EFFECTS IN THE PRODUCT INSTRUCTION FOR USE. 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 VIA A TRIAL THAT TWO HOURS AFTER A LEFT INTERNAL CAROTID STENTING PROCEDURE WITH A RX ACCULINK, THE PATIENT EXPERIENCED TRANSIENT SLURRED SPEECH WITH HYPOTENSION. THE PATIENT WAS TREATED WITH A NEOSYNEPHRINE INFUSION AND LOVENOX. THE SLURRED SPEECH RESOLVED WITHIN TWENTY FOUR HOURS AND THE HYPOTENSION RESOLVED WITHIN FORTY EIGHT HOURS. THE PATIENT WAS DISCHARGED HOME THREE DAYS AFTER THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA. 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 8042151

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R EMBOLIC PROTECTION: RX ACCUNETBIVALIRUDIN