BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE OTW NITINOL STENT

    MDR report key: 1190315 · Received October 6, 2008

    Report

    Report Number
    9616099-2008-02393
    Event Type
    Injury
    Date Received
    October 6, 2008
    Date of Event
    August 26, 2008
    Report Date
    September 10, 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

    ADD'L INFO WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THIS MALE PT WITH A HISTORY OF STROKE, HYPERTENSION AND HYPERURICEMIA WAS ADMITTED FOR CAROTID ARTERY ANGIOGRAM DUE TO STROKE-LIKE SYMPTOMS. ANGIOGRAPHY REVEALED A 56%, MILDLY CALCIFIED LESION IN THE RIGHT INTERNAL CAROTID ARTERY. THE VESSEL WAS DESCRIBED AS MODERATELY TORTUOUS. THE FOLLOWING MEDICATIONS WERE ADMINISTERED: PRE-PROCEDURE: CILOSTAZOL, INTRA-PROCEDURE: HEPARIN, POST-PROCEDURE: EDARAVONE. THE ANGIOGUARD DELIVERY AND THE STENT PLACEMENT WERE SUCCESSFUL. THE STENT WAS POST DILATED AND GOOD STENT-WALL APPOSITION WAS CONFIRMED. AFTER STENT PLACEMENT, THE PHYSICIAN CONFIRMED THAT THE SOFT PLAQUE PROTRUDED OUT THE STENTED AREA. FOUR (4) HRS AFTER THE PROCEDURE, THE PT HAD PARALYSIS ON HIS LEFT UPPER EXTREMITY. NEXT DAY, AN INFARCT IN THE RIGHT PYRAMIDAL AREA WAS CONFIRMED WITH MRI. THIS WAS TREATED WITH RADICUT AND THE PT HAD FULL RECOVERY WITHIN FOUR (4) DAYS. THE PHYSICIAN THINKS THAT THIS EVENT WAS DUE TO SMALL CLOTS THAT EMBOLIZED WHEN THE TARGET PLAQUE WAS RUPTURED.

    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 13413232

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| L| R ANGIOGUARD| PTA BALLOON| CILOSTAZOL| INTRA-PROCEDURE: HEPARIN| POST-PROCEDURE: EDARAVONE