BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE OTW NITINOL STENT

    MDR report key: 1082290 · Received July 25, 2008

    Report

    Report Number
    9616099-2008-01851
    Event Type
    Injury
    Date Received
    July 25, 2008
    Date of Event
    May 29, 2008
    Report Date
    July 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 IS DISTRIBUTED OUTSIDE THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE US DISTRIBUTED DRUG-ELUTING STENTS. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED EVENT. THE ASSOCIATED MFR REPORT NUMBER IS 1016427-2008-00206. ADD'L INFO WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    CAS: THE TARGET LESION WAS INTERNAL CAROTID ARTERY. THERE WAS NO CALCIFICATION OR VESSEL TORTUOSITY, 70% STENOSIS. THE PT WAS A MALE. THE APPROACH SITE WAS RIGHT FEMORAL ARTERY. THE LENGTH OF THE TARGET LESION WAS ABOUT 25MM. THE LESION WAS PRE-DILATED WITH 3MM DIAMETER BALLOON, AND POST-DILATED WITH 4MM DIAMETER BALLOON. MFR OF THE BALLOONS IS UNK. THE PT DEVELOPED TIA DURING THE PROCEDURE, BUT RECOVERED AFTER RECEIVING RADICUT BY IV. BOTH THE ANGIOGUARD AND THE PRECISE STENT WERE IN THE PT AT THE TIME OF THE TIA. THERE WAS DEBRIS IN THE ANGIOGUARD BASKET, BUT IT IS UNK WHETHER THE BASKET WAS SUCTIONED OR NOT. THE PHYSICIAN COMMENTED THAT THE CAUSE OF TIA MIGHT BE THAT THE BLOOD FLOW SLOWED DURING THE PROCEDURE, AND EMBOLICS COULD BE PRODUCED BY COMPRESSING PLAQUE WHILE STENT PLACEMENT. THERE WAS NO CONFIRMED INFARCT REGION UNDER MRI INSPECTION. THE PT WAS DISCHARGED WITHOUT ANY AFTER EFFECTS.

    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 13384987

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention