BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE OTW NITINOL STENT

    MDR report key: 1241282 · Received November 21, 2008

    Report

    Report Number
    9616099-2008-02662
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    July 11, 2008
    Report Date
    November 4, 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 WILL NOT BE RETURN FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SENT WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    REPORT RECEIVED INDICATED THAT PATIENT EXPERIENCED RETINAL ARTERIAL OCCLUSION TWO DAYS POST STENT PLACEMENT. THE PRECISE STENT PLACEMENT WITH PERCUSURGE WAS SUCCESSFUL. TWO DAYS AFTER THE PROCEDURE, THE LEFT VISION OF THE PATIENT WAS DROPPED FROM 20/28 TO 20/200. THE PHYSICIAN THINKS THE PATIENT HAS HAD CENTRAL RETINAL ARTERY OCCLUSION IN THE PAST, THEREFORE, IT MAY HAVE RETURNED AT THIS TIME. CAROTID STENTING WAS PERFORMED TO THE LEFT INTERNAL ARTERY. THERE WAS HEAVY CALCIFICATION, NO VESSEL TORTUOSITY AND THE RATE OF STENOSIS WAS 99%. THERE WAS NO THROMBUS. THE PATIENT DID NOT EXHIBIT ANY ADVERSE EVENT DURING THE PROCEDURE. THERE WAS NO INTERVENTION OR TREATMENT PROVIDED. IT IS UNKNOWN IF EVENT WAS RELATED TO THE DEVICE, HOWEVER, THE PATIENT HAS A HISTORY OF MILD CENTRAL RETINAL ARTERY OCCLUSION IN THE PAST. ACCORDING TO THE PHYSICIAN, OVERALL THE PATIENT'S CONDITION IS MUCH BETTER THAN BEFORE THE PROCEDURE.

    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 13166587

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Disability