BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 1180167 · Received September 29, 2008

    Report

    Report Number
    3004742046-2008-00236
    Event Type
    Injury
    Date Received
    September 29, 2008
    Date of Event
    September 9, 2008
    Report Date
    September 9, 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
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. STUDY REPORT. THE STENT REMAINS IN THE PATIENT. THE LOT NUMBER WAS NOT IDENTIFIED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: STENT FRACTURE. SYMPTOMS/AE: IN-STENT RESTENOSIS. TIME OF AE: APPROXIMATELY 11 MONTHS POSTPROCEDURE. IT WAS REPORTED THAT APPROXIMATELY 11 MONTHS POST A RIGHT INTERNAL CAROTID ARTERY STENTING PROCEDURE, THE PATIENT WAS FOUND TO HAVE IN-STENT RESTENOSIS WITH A POSSIBLE STENT FRACTURE. THE PATIENT WAS REHOSPITALIZED AND HAD ANGIOPLASTY WITH A VIATRAC BALLOON. THERE WERE NO REPORTED ADVERSE PATIENT 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R