BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE OTW NITINOL STENT

    MDR report key: 1031096 · Received April 17, 2008

    Report

    Report Number
    9616099-2008-01014
    Event Type
    Injury
    Date Received
    April 17, 2008
    Date of Event
    March 4, 2008
    Report Date
    April 15, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION TO BE SUBMITTED 30 DAYS UPON RECEIPT. PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF TWO PRODUCTS INVOLVED IN THE SAME PROCEDURE ASSOCIATED WITH MFG. REPORT# 1016427-2008-00092.

    Description of Event or Problem · 1

    FOLLOWING A CAROTID STENTING PROCEDURE, THE PATIENT DEVELOPED HEMIPLEGIA, DYSARTHRIA, AND CONSCIOUSNESS DISORDER. THE DIAGNOSIS WAS A BRAIN INFARCTION. IT IS UNKNOWN HOW LONG AFTER THE PROCEDURE THE SYMPTOMS OCCURRED. THE PATIENT RECEIVED IV TREATMENT (NAME OF MEDICATION UNKNOWN) AND HYPERBARIC OXYGEN THERAPY. THE PATIENT WAS A MALE. THE TARGET LESION WAS CAROTID ARTERY (NO FURTHER DETAIL IS PROVIDED). THERE IS NO INFORMATION ABOUT THE TARGET CHARACTERISTICS. THE RATE OF STENOSIS IS UNKNOWN. THE PATIENT WAS ANTICOAGULATED (MEDS UNKNOWN). THERE WAS NO MALFUNCTION OF THE ANGIOGUARD DISTAL PROTECTION DEVICE OR THE PRECISE STENT. AFTER 30 DAYS POST PROCEDURE, THE HEMIPLEGIA, DYSARTHRIA AND CONSCIOUSNESS DISORDER HAD RESOLVED, BUT MEMORY DISORDER APPEARED, AND THE PATIENT'S NEUROGENIC BLADDER DYSFUNCTION HAD WORSENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISE OTW NITINOL STENT SELF EXPANDING STENTS (NIM) NIM CORDIS DE MEXICO NA 13284837

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| L| R