BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 1011244 · Received March 6, 2008

    Report

    Report Number
    9616695-2008-00016
    Event Type
    Injury
    Date Received
    March 6, 2008
    Date of Event
    February 11, 2008
    Report Date
    February 12, 2008
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE STENT REMAINS IN THE PATIENT. THE LOT NUMBER WAS PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: PARTIALLY DAMAGED STENT. SYMPTOMS/AE: VESSEL DISSECTION. TIME OF MALFUNCTION/AE: DURING THE PROCEDURE. IT WAS REPORTED THAT DURING THE RIGHT INTERNAL CAROTID ARTERY STENTING PROCEDURE, IMMEDIATELY POST XACT STENT PLACEMENT, AN ANGIOGRAM REVEALED A POSSIBLE KINK AT THE DISTAL EDGE OF THE STENT AND A VESSEL DISSECTION. A SECOND COMPETITOR STENT WAS POSITIONED ACROSS THE DISTAL STENT EDGE AND WAS DEPLOYED SUCCESSFULLY. THE PATIENT REMAINED HEMODYNAMICALLY STABLE DURING THE PROCEDURE. ONE DAY POST PROCEDURE, THE PATIENT WAS DISCHARGED TO HOME. THERE WAS NO ADVERSE SEQUELAE REPORTED. STUDY EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XACT CAROTID STENT SYSTEM NIM ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 444727

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EMBOSHIELD| HEPARIN| ZILVER 6X40