BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE OTW NITINOL STENT

    MDR report key: 1040535 · Received May 9, 2008

    Report

    Report Number
    9616099-2008-01266
    Event Type
    Injury
    Date Received
    May 9, 2008
    Date of Event
    March 27, 2008
    Report Date
    May 1, 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.

    Description of Event or Problem · 1

    THE DAY AFTER THE INDEX PROCEDURE, THE PT DEVELOPED A FUNDAL HEMORRHAGE (LOCATED AT THE RIGHT FUNDUS OCULI) AND A SUBARACHNOID HEMORRHAGE. THE PT ALSO DEVELOPED LEFT-SIDED HEMIPLEGIA. THIS MALE PT HAD A STENT PLACED IN THE CAROTID ARTERY (SIDE UNK) IN 2008. THE PROCEDURE WAS CARRIED OUT WITHOUT COMPLICATIONS, AND THE PT WAS NEUROLOGICALLY INTACT WHEN TAKEN FROM THE ANGIO SUITE. THERE WAS NO MALFUNCTION WITH THE ANGIOGUARD DISTAL PROTECTION DEVICE OR THE PRECISE STENT. THE NEXT DAY, THE PT DEVELOPED A FUNDAL HEMORRHAGE (LOCATED AT THE RIGHT FUNDUS OCULI) AND A SUBARACHNOID HEMORRHAGE. THERE IS NO INFORMATION AS TO WHAT CAUSED THE HEMORRHAGE. THERE WAS NO PRESENCE OF AN ANEURYSM. AFTER THE HEMORRHAGE OCCURRED, THE PT DEVELOPED LEFT-SIDED HEMIPLEGIA. THE PT WAS KEPT UNDER STRICT BLOOD PRESSURE CONTROL, WITH SEDATIVES AND ENDOTRACHEAL INTUBATION. THE PT IS CURRENTLY STABLE AND CLEARLY CONSCIOUS.

    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 13324222

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| L| R ANGIOGUARD DISTAL PROTECTION DEVICE