BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 1061197 · Received June 16, 2008

    Report

    Report Number
    3004742046-2008-00141
    Event Type
    Injury
    Date Received
    June 16, 2008
    Date of Event
    June 14, 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
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE STENT REMAINS IN THE PATIENT. THE LOT NUMBER WAS NOT IDENTIFIED; THEREFORE, A DEVICE HISTORY RECORD COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: MISPLACED. TIME OF MALFUNCTION: DURING THE PROCEDURE. SYMPTOMS/AE: VASOSPASM. TIME OF SYMPTOMS/AE: DURING THE PROCEDURE. IT WAS REPORTED THAT DURING A RIGHT INTERNAL CAROTID ARTERY STENTING PROCEDURE, THE STENT JUMPED DURING DEPLOYMENT APPROXIMATELY A CENTIMETER AND A HALF, NOT COVERING THE MOST PROXIMAL PART OF THE LESION. THEREFORE, A SECOND RX ACCULINK WAS SUCCESSFULLY DEPLOYED, OVERLAPPING THE PROXIMAL END OF THE FIRST STENT. ADDITIONALLY, AFTER THE EMBOLIC PROTECTION DEVICE WAS RETRIEVED, ANGIOGRAMS SHOWED A VASOSPASM DISTAL TO THE STENTS. NITROGLYCERIN WAS ADMINISTERED INTRA-ARTERIALLY. THE PATIENT REMAINED NEUROLOGICALLY INTACT AND WAS DISCHARGED HOME 5 DAYS POST PROCEDURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 5X30 VIATRAC BALLOON| AMPLATZ SUPER STIFF WIRE| RX ACCUNET| MAGIC TORQUE WIRE| 4X30 MAVERICK BALLOON| BIVALIRUDIN| 6F SHEATH| 8F SHEATH| 5F CATHETER| 8F GUIDING CATHETER