BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 1388076 · Received May 18, 2009

    Report

    Report Number
    3004742046-2009-00119
    Event Type
    Injury
    Date Received
    May 18, 2009
    Date of Event
    May 29, 2007
    Report Date
    April 24, 2009
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    STUDY EVENT. THE STENT REMAINS IN THE PT. THE LOT NUMBER WAS PROVIDED. RESTENOSIS OF STENTED SEGMENT IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE USE OF THE DEVICE AS LISTED IN THE RX ACCULINK INSTRUCTIONS FOR USE. THERE WAS NO DEVICE MALFUNCTION REPORTED. A REVIEW OF THE FINISH DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMITIES WHICH COULD HAVE CONTRIBUTED TO THIS EVENT. DEVICE #1 RX ACCULINK PART # 1011342-30, LOT # 6042051, IS BEING FILED UNDER A SEPARATE MEDWATCH MFR # 3004742046-2009-00118.

    Description of Event or Problem · 1

    DEVICE #2 (LICA) MALFUNCTION: NONE. SYMPTOMS/ AE: IN-STENT RESTENOSIS. TIME OF AE: APPROXIMATELY 8 MONTHS POST PROCEDURE. IT WAS REPORTED THAT APPROXIMATELY 8 MONTHS POST A LEFT INTERNAL (LICA) AND COMMON CAROTID (LCCA) ARTERY STENTING PROCEDURE IN 2007, THE PT RETURNED TO THE CATHETER LAB FOR TREATMENT OF IN-SENT RESTENOSIS. THE LICA AND 60% IN-SENT RESTENOSIS AND THE LCCA HAD 90% IN-STENT RESTENOSIS. CAROTID ANGIOPLASTY WAS PERFORMED. THERE WAS NO ADVERSE PT SEQUELAE REPORTED. ALTHOUGH REQUESTED, THERE WAS NO ADDITIONAL INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ACCULINK CAROTID STENT SYSTEM NIM ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 6081651

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention DEVICE #1: RX ACCULINK| LOT # 6042051