BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISE OTW NITINOL STENT

    MDR report key: 1081985 · Received July 22, 2008

    Report

    Report Number
    9616099-2008-01821
    Event Type
    Malfunction
    Date Received
    July 22, 2008
    Date of Event
    June 26, 2008
    Report Date
    July 2, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FILMS WERE RECEIVED FOR EVALUATION AND HAVE BEEN SENT TO AN INDEPENDENT FILM REVIEWER. THIS PRODUCT WILL NOT BE RETURNED FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SENT WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    REPORT RECEIVED INDICATED THE PRECISE STENT STRUTS WERE FOUND FRACTURED. THERE WERE NO DIFFICULTIES OR COMPLICATION EXPERIENCED DURING THE INDEX PROCEDURE AND THE STENT DEPLOYMENT WAS SUCCESSFUL. THE TARGET LESION WAS THE COMMON-INTERNAL CAROTID ARTERY. THE COMMON CAROTID MEASURE 10MM AND THE INTERNAL CAROTID ARTERY MEASURED 6MM. THE ARTERY WAS DESCRIBED, AS STRAIGHT WITHOUT CALCIFICATIONS. THE RATE OF STENOSIS IS UNKNOWN. A THREE-MONTH FOLLOW UP WAS MADE AND WAS DISCOVERED THE STENT STRUTS WERE FRACTURED NEAR THE MIDDLE OF THE STENT. THE STENT WAS SEEN ON FILM EXTENDED 0.8MM LONG COMPARED WITH THE FILMS THAT WERE TAKEN JUST AFTER THE PROCEDURE. OF NOTE, THE PHYSICIAN MENTIONED THE INDEX PROCEDURE WAS COMPLETED AS USUAL WITHOUT ANY DIFFICULTIES. ADDITIONALLY, IT WAS UNLIKELY THAT THE DEVICES USED IN CONJUNCTION, AND HIS TECHNIQUE IMPACTED ON THE STENT AND CAUSED THE STENT TO FRACTURE. ALSO THE PATIENT WAS INTERVIEWED AND REPORTED THAT THERE WAS NO MASSAGE FOR HIS NECK AFTER THE CAROTID ARTERY STENTING. THERE WAS NO KNOWN EXTERNAL FORCE ON THE NECK. THE PATIENT IS ASYMPTOMATIC AND STABLE. THE PHYSICIAN IS PLANNING TO CONDUCT ANGIOSCOPIC EXAMINATION AND DECIDE IF INTERVENTION IS REQUIRED.

    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 13285619

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR ANGIOGUARD XP 5MM/ CORDIS| 8F STRAIGHT BRIGHT TIP GUIDING CATHETER/CORDIS| AMIIA BALLOON CATHETER/CORDIS| BALLOON CATHETER/BOSTON SCIENTIFIC