BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 700950 · Received April 17, 2006

    Report

    Report Number
    3004742046-2006-00164
    Event Type
    Injury
    Date Received
    April 17, 2006
    Date of Event
    August 25, 2005
    Report Date
    March 20, 2006
    Manufacturer
    GUIDANT ENDOVASCULAR SOLUTIONS
    Product Code
    NIM
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PRODUCT COMPLICATION: NONE. TIME OF COMPLICATION: ADDITIONAL VISIT, START DATE 8/25/2005, STOP DATE 2005. THE CAROTID PROCEDURE DATE WAS IN 2005. SYMPTOMS: CHEST PAIN AND ITCHING. IT WAS REPORTED THAT AT AN ADDITIONAL VISIT 08/25/2005, THE PT HAD EXPERIENCED CHEST PAIN AND ITCHING AFTER DISCHARGE FROM THE HOSP FOR A STENT PROCEDURE IN 2006. THE PT WAS RE-HOSPITALIZED 3 DAYS LATER AND UNDERWENT LEFT HEART CATHERIZATION, ANGIOPLASTY 3 DAYS LATER AND SECOND STENT OPERATION THE FOLLOWING DAY NEITHER OPERATION WAS PLANNED. THE CONDITION WAS PRE-EXISTING AND WAS NOT FELT TO BE RELATED TO THE DEVICE. THIS EVENT RESULTED IN NEW HOSPITALIZATION WITH INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE. THE PT'S OUTCOME WAS REPORTED TO BE RESOLVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization