BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE OTW NITINOL STENT

    MDR report key: 1021287 · Received March 25, 2008

    Report

    Report Number
    9616099-2008-00785
    Event Type
    Injury
    Date Received
    March 25, 2008
    Date of Event
    January 12, 2008
    Report Date
    March 7, 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 OF THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE SAME PRODUCT DISTRIBUTED IN THE UNITED STATES. THIS IS ONE OF TWO PRODUCTS INVOLVED IN THE SAME PATIENT REPORTED UNDER MANUFACTURING NUMBERS 1016427-2008-00086 AND 9616099-2008-00785. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE REPORT INDICATED THAT AS PATIENT HAD HYPOTENSION AND AN INCREASE IN INFARCT ZONE AFTER IMPLANTATION OF A PRECISE SELF-EXPANDING STENT. THE TARGET LESION WAS THE CAROTID; VESSEL AND LESION CHARACTERISTICS ARE NOT AVAILABLE AND IS UNKNOWN IF THE TARGET CAROTID WAS THE LEFT OR THE RIGHT. AN ANGIOGUARD WAS IN USE DURING THE PROCEDURE AND SUCTION WAS NOT CONDUCTED DURING THE PROCEDURE. IT IS NOT KNOWN IF PREDILATATION AND POST DILATATION WAS CONDUCTED. THE PATIENT PRESENTED FOR THE PROCEDURE WITH ALOGIA AND AN INFARCTED DEUTOCEREBRUM. AN ANGIOGUARD WAS IN USE DURING THE PROCEDURE AND SUCTION WAS NOT CONDUCTED DURING THE PROCEDURE. IT IS NOT KNOWN IF PREDILATATION AND POST DILATATION WAS CONDUCTED. AFTER THE PROCEDURE, THE PATIENT STILL HAD ALOGIA BUT BECAME HYPOTENSIVE AND AN INCREASE IN THE INFARCT ZONE AT THE DEUTOCEREBRUM WAS NOTED ON MAGNETIC RESONANCE IMAGING (MRI). THE HYPOTENSION WAS TREATED WITH NORADRENALINE WITH GOOD RESULTS. IT REMAINS UNKNOWN HOW LONG AFTER THE PROCEDURE THE INCREASE OF THE INFARCT ZONE OCCURRED AND IT IS NOT KNOWN WHAT MAY HAVE CAUSED IT.

    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 Required Intervention ANGIOGUARD