BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE RX NITINOL STENT

    MDR report key: 1062918 · Received June 19, 2008

    Report

    Report Number
    9616099-2008-01554
    Event Type
    Injury
    Date Received
    June 19, 2008
    Date of Event
    May 27, 2008
    Report Date
    May 27, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR THREE UNK PRECISE STENTS. THE PRODUCTS ARE NOT AVAILABLE FOR ANALYSIS. ADD'L INFO WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT. THERE IS ALSO AN ANGIOGUARD DEVICE ASSOCIATED WITH THIS EVENT. PLEASE REFER TO MFR REPORT #1016427-2008-00177.

    Description of Event or Problem · 1

    THE PT WAS A MALE. THE TARGET LESION WAS LEFT INTERNAL CAROTID ARTERY. THERE WAS MODERATE CALCIFICATION, MILD TORTUOSITY AND 85% STENOSIS. THE CAROTID ARTERY STENTING PROCEDURE WAS CARRIED OUT WITHOUT MAJOR COMPLICATION. THREE PRECISE STENTS (CATALOG/LOT UNK) WERE PLACED, AND THEN BLOOD FLOW WAS SLOWED SLIGHTLY. THE FILTER BASKET WAS SUCTIONED AND THE ANGIOGUARD PROTECTION DEVICE WAS REMOVED SAFELY. AFTER THE PROCEDURE, THE PT COULDN'T SPEAK CLEARLY, THOUGH HE COULD ANSWER PHYSICIAN'S QUESTIONS. NO DYSKINESIA WAS SEEN. PRECENTRAL LESION OF LEFT MIDDLE CEREBRAL ARTERY WAS NOT SEEN ON ANGIOGRAPHY. MEDICAL TREATMENT (RADICUT) AND REHABILITATION ARE PLANNED FOR FUTURE TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISE RX NITINOL STENT SELF EXPANDING STENTS NIM CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention BRITETIP GC (CAT/LOT UNK)| ANGIOGUARD PROTECTION DEVICE