BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 1061196 · Received June 16, 2008

    Report

    Report Number
    3004742046-2008-00140
    Event Type
    Injury
    Date Received
    June 16, 2008
    Date of Event
    May 16, 2007
    Report Date
    May 23, 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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    STUDY EVENT. THE STENT REMAINS IN THE PATIENT. THE LOT NUMBER WAS PROVIDED. A REVIEW OF THE DEVICE LOT HISTORY RECORD IS FORTHCOMING. A FOLLOW-UP WILL BE SUBMITTED WITH ANY RELEVANT INFORMATION.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: MISPLACED. TIME OF MALFUNCTION: DURING THE PROCEDURE. SYMPTOMS/AE: NONE. IT WAS REPORTED THAT DURING A LEFT INTERNAL CAROTID ARTERY STENTING PROCEDURE, THE RX ACCULINK STENT JUMPED A LITTLE INFERIOR TO THE LESION AND PROXIMALLY INTO THE COMMON CAROTID ARTERY. A SECOND RX ACCULINK STENT WAS PLACED DISTALLY INTO THE INTERNAL CAROTID ARTERY TO COMPLETELY COVER THE LESION. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS. ALTHOUGH REQUESTED, THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ACCULINK CAROTID STENT SYSTEM NIM ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 7020651

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention HEPARIN