BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 1032348 · Received April 22, 2008

    Report

    Report Number
    3004742046-2008-00088
    Event Type
    Injury
    Date Received
    April 22, 2008
    Date of Event
    October 8, 2007
    Report Date
    March 31, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE STENT REMAINS IN THE PATIENT. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE LOT HISTORY RECORD DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT. ANGIOGRAM IMAGES WERE RECEIVED AND REVIEWED CONFIRMING THERE IS RESTENOSIS WITHIN THE INTERNAL CAROTID PART OF THE STENT, LIKELY DUE TO INTIMAL HYPERPLASIA.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: NONE. SYMPTOMS/AE: IN-STENT RESTENOSIS. TIME OF SYMPTOMS/AE: 8 MONTHS POST-PROCEDURE. IT WAS REPORTED THAT APPROXIMATELY 8 MONTHS POST AN UNEVENTFUL RIGHT INTERNAL CAROTID ARTERY STENTING PROCEDURE, ROUTINE ANGIOGRAM REVEALED IN-STENT RESTENOSIS. THERE WERE NO REPORTED NEUROLOGICAL PATIENT SEQUELAE. THE RE-STENOSIS WAS SUCCESSFULLY TREATED WITH ANGIOPLASTY. ALTHOUGH REQUESTED, THERE IS NO ADDITIONAL INFORMATION AVAILABLE. STUDY EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ACCULINK CAROTID STENT SYSTEM NIM ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 6121951

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R HEPARIN| RX ACCUNET X2