BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE OTW NITINOL STENT

    MDR report key: 1053427 · Received May 27, 2008

    Report

    Report Number
    9616099-2008-01396
    Event Type
    Injury
    Date Received
    May 27, 2008
    Date of Event
    April 30, 2008
    Report Date
    April 30, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS DISTRIBUTED OUTSIDE THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE US DISTRIBUTED DRUG-ELUTING STENTS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE TARGET LESION WAS CAROTID ARTERY. THERE IS NO INFORMATION ABOUT THE TARGET CHARACTERISTICS. THE PATIENT WAS FEMALE, AGE UNKNOWN. A PRECISE STENT WAS DELIVERED TO THE LESION WITH NO PROBLEM AND AN ANGIOGUARD WAS SUCCESSFULLY DELIVERED AND RETRIEVED DURING THE PROCEDURE. THE CAS PROCEDURE WAS FINISHED WITHOUT ANY ABNORMALITY, BUT THE PATIENT DEVELOPED PARALYSIS ON THE RIGHT ARM AFTER THE PROCEDURE. NO SYMPTOM WAS SEEN DURING THE PROCEDURE. THE PARALYSIS IS RECOVERING, BUT NOT COMPLETELY DISSOLVED. SHE IS IN STABLE CONDITION, AND NO MEDICAL TREATMENT HAS BEEN GIVEN FOR THE PARALYSIS. THERE IS NO ADDITIONAL INFORMATION REGARDING THIS CASE.

    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 13126897

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization ANGIOGUARD