BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 1002319 · Received February 22, 2008

    Report

    Report Number
    3004742046-2008-00040
    Event Type
    Injury
    Date Received
    February 22, 2008
    Date of Event
    November 2, 2007
    Report Date
    January 28, 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
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE STENT REMAINS IN THE PT; THE STENT DELIVERY SYSTEM WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. A REVIEW OF THE DEVICE HISTORY FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Description of Event or Problem · 1

    STUDY EVENT. DEVICE MALFUNCTION: NONE. TIME OF MALFUNCTION: AFTER PROCEDURE. SYMPTOMS/AE: HYPOTENSION. IT WAS REPORTED THAT ONE DAY AFTER AN UNEVENTFUL LEFT COMMON AND INTERNAL CAROTID ARTERY STENTING PROCEDURE, THE PT EXPERIENCED AN EPISODE OF BLURRED VISION IN THE RIGHT HEMIFIELD WHICH RESOLVED IN 30 MINUTES. THE PT ALSO EXPERIENCED ORTHOSTATIC HYPOTENSION. VASOPRESSORS/INOTROPES WERE ADMINISTERED. THE PT WAS SYMPTOMATIC FOR 4 DAYS AND WAS DISCHARGED TO HOME FIVE DAYS POST-PROCEDURE. REPORTEDLY, HIS CONDITION IS IMPROVED BUT CONTINUING. THOUGH REQUESTED, NO ADD'L INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ACCULINK CAROTID STENT SYSTEM NIM ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 7090451

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization HEPARIN