BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 767260 · Received October 3, 2006

    Report

    Report Number
    3004742046-2006-00405
    Event Type
    Injury
    Date Received
    October 3, 2006
    Date of Event
    September 7, 2006
    Report Date
    September 7, 2006
    Manufacturer
    ABBOTT ENDOVASCULAR SOLUTIONS
    Product Code
    NIM
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RX ACCUNET PART#1011649-65, LOT#6020951; IS BEING REPORTED UNDER MANUFACTURER REPORT NUMBER 3004742046-2006-00404.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: NONE; TIME OF SYMPTOMS/AE: DURING PROCEDURE; SYMPTOMS/AE: HYPOTENSION, NEUROLOGICAL/HYPERFUSION SYNDROME. IT WAS REPORTED THAT DURING A CAROTID STENT PROCEDURE OF THE LIC, THE STENT HAD BEEN SUCCESSFULLY DEPLOYED AND URING POST-DILATATION THE PATIENT EXPERIENCED HYPOTENSION AND STROKE-LIKE SYMPTOMS OF SLURRED, INCOHERENT SPEECH. THIS LASTED FOR A FEW MINUTES, BUT WAS NOTED TO RESOLVE WITHIN ABOUT 30 MINUTES. IT WAS FURTHER NOTED THAT THE PHYSICIAN SUSPECTED THIS MAY HAVE BEEN A CEREBRAL HYPERFUSION SYNDROME. DURING THE PROCEDURE, A CEREBRAL ANGIO-SHOT WAS DONE AND THE PHYSICIAN REMARKED THAT IT LOOKED "OK". NO ADDITIONAL MEDICATION WAS ADMINISTERED FOR THE NOTED SYMPTOMS. THE PATIENT WAS SENT TO ICU FOR OVERNIGHT MONITORING. IT WAS ALSO NOTED THAT A STEROID WAS USED, BUT THE TREATMENT SYMPTOM WAS NOT REPORTED. DATE OF DISCHARGE WAS REPORTED AS THREE DAYS AFTER EVENT DAY IN 2006. NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ACCULINK CAROTID STENT SYSTEM CAROTID STENT SYSTEM NIM ABBOTT ENDOVASCULAR SOLUTIONS NA 6041051

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization DILATATION CATHETER: VOYAGER 3.0X20MM| ULTRASOFT 5.0X20MM| GUIDE WIRE: AMPLATZ, GLIDE WIRE| SHEATH: COOK 6F FLEXOR| OTHER: RX ACCUNET