BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 1063203 · Received June 19, 2008

    Report

    Report Number
    3004742046-2008-00142
    Event Type
    Injury
    Date Received
    June 19, 2008
    Date of Event
    May 28, 2008
    Report Date
    May 30, 2008
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    NIM
    PMA / PMN Number
    P040012
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    STUDY EVENT. THE STENT REMAINS IN THE PT. THE LOT NUMBER WAS PROVIDED. THE LOT HISTORY RECORD WAS REVIEWED. THERE ARE NO NON-CONFORMANCES ASSOCIATED WITH THIS LOT NUMBER. NEUROLOGICAL EVENTS, HYPOTENSION, AND HEADACHES MAY OCCUR DURING THIS TYPE OF PROCEDURE AND AS LISTED IN THE DEVICE INSTRUCTIONS FOR USE. ADDITIONALLY, THERE WERE NO DEVICE ISSUES REPORTED.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: NONE. SYMPTOMS / AE: HYPOTENSION. TIME OF AE: DURING THE PROCEDURE. IT WAS REPORTED THAT DURING A LEFT INTERNAL CAROTID ARTERY STENTING PROCEDURE AFTER PLACEMENT OF THE STENT, THE PT BECAME HYPOTENSIVE AND HAD SOME VISUAL DISTURBANCES. THE VISUAL DISTURBANCES RESOLVED ONE MINUTE LATER. ZOFRAN WAS GIVEN AND A DOPAMINE DRIP WAS STARTED. A HEAD CT WAS DONE SHOWING NO SIGNIFICANT DIFFERENCE FROM A PREVIOUS SCAN. ADDITIONALLY, AT THE END OF THE PROCEDURE, THE PT REPORTED A SEVERE HEADACHE WHICH WAS TREATED WITH VERSED AND FENTANYL. HEADACHE PAIN REPORTEDLY DECREASED BUT WAS NOT RESOLVED. ONE DAY POST PROCEDURE, THE PT WAS SEEN BY A NEUROLOGIST WITH NO NEW NEUROLOGICAL CHANGES. THREE DAYS POST PROCEDURE, THE HEADACHE AND HYPOTENSION RESOLVED AND THE PT WAS DISCHARGED TO HOME. ALTHOUGH REQUESTED, THERE IS NO ADD'L INFO AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ACCULINK CAROTID STENT SYSTEM NIM ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 7110652

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R RX ACCUNET EMBOLIC PROTECTION DEVICE