BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 1060668 · Received June 13, 2008

    Report

    Report Number
    3004742046-2008-00138
    Event Type
    Injury
    Date Received
    June 13, 2008
    Date of Event
    May 8, 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
    MI, 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 FINISHED DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMITIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT. RESTENOSIS OF THE STENTED SEGMENT MAY OCCUR DURING THIS TYPE OF PROCEDURE AS LISTED IN THE INSTRUCTIONS FOR USE. NO DEVICE MALFUNCTION WAS DESCRIBED. THE RX ACCULINK PART # 1011343-30, LOT # UNK, IS BEING FILED UNDER MANUFACTURER REPORT NUMBER 3004742046-2008-00137.

    Description of Event or Problem · 1

    SYMPTOMS/AE: IN-STENT RESTENOSIS. TIME OF AE: APPROXIMATELY 10 MONTHS POST STENTING. IT WAS REPORTED THAT APPROXIMATELY 10 MONTHS POST A LEFT INTERNAL CAROTID ARTERY STENTING PROCEDURE, THE PATIENT HAD HIGH GRADE IN-STENT RESTENOSIS-90% STENOSIS. INITIALLY, AT AN UNKNOWN TIME, THIS VESSEL UNDERWENT A CAROTID ENDARTERECTOMY. DUE TO RESTENOSIS OF THE VESSEL, IN 2005, THE VESSEL WAS STENTED WITH AN RX ACCULINK. APPROXIMATELY ONE YEAR POST PROCEDURE, IN 2006, A STENT WAS PLACED WITHIN THE STENT DUE TO ASYMPTOMATIC RESTENOSIS. APPROXIMATELY 10 MONTHS POST THE SECOND STENTING PROCEDURE, THE PATIENT WAS AGAIN FOUND TO HAVE SIGNIFICANT ASYMPTOMATIC IN-STENT RESTENOSIS. A THIRD RX ACCULINK WAS PLACED TO REOPEN THE VESSEL. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ACCULINK CAROTID STENT SYSTEM NIM ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 5012751

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R STARCLOSE| RX ACCULINK PART # 1011343-30| LOT # UNK| RX ACCUNET EMBOLIC PROTECTION DEVICE| HEPARIN