BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRECISE RX NITINOL STENT

    MDR report key: 1162663 · Received September 16, 2008

    Report

    Report Number
    9616099-2008-02258
    Event Type
    Death
    Date Received
    September 16, 2008
    Date of Event
    March 5, 2008
    Report Date
    August 21, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT WIL NOT BE RETURNED FOR EVAL AND TESTING. ADDITIONAL INFO WILL BE SENT WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    REPORT RECEIVED INDICATED THAT PT DIED (6 MONTHS POST STENT IMPLANT). THE PT WAS CONSENTED TO THE STUDY FOR CAROTID STENTING. AT BASELINE THE SUBJECT WAS EVALUATED WITH NIH (NATIONAL INSTITUTES OF HEALTH) STROKE SCALE SCORE OF (1) AND A RANKIN STROKE SCALE SCORE OF (0). THE PT WAS ASYMPTOMATIC. THE TARGET LESION WAS LOCATED AT THE PROXIMAL LEFT EXTERNAL CAROTID ARTERY. THERE WAS NO OCCLUSION IN THE CONTRALATERAL SIDE. THE TARGET LESION DIAMETER STENOSIS WAS 75% WITH LESION LENGTH 20.0MM AND REFERENCE DIAMETER OF 5.0MM. TOTAL LENGTH OF STENTED SEGMENT WAS 40.0MM. THE GEOMETRY OF THE TARGET LESION WAS DESCRIBED AS ECCENTRIC AND ULCERATED. THE LESION WAS PREDILATED AND MILDLY CALCIFIED. THE PT HAD AN ARCH TYPE I. THE VESSEL TORTUOSITY WAS NOT DOCUMENTED. THROMBUS WAS NOT SEEN AT THE LESION SITE. ANGIOGUARD DISTAL PROTECTION DEVICE AND PRECISE RX NITINOL STENT (P08040RXC/13235044) WERE PREPPED AND USE DURING PROCEDURE. THE STENT WAS IMPLANTED AT THE INTENDED TARGET SITE WITH OUT INCIDENT. THE DISTAL PROTECTION DEVICE WAS DEPLOYED AND RETRIEVED WITHOUT TECHNICAL PROBLEMS. UPON RETRIEVAL OF THE ANGIOGUARD DEVICE THERE WAS NO DEBRIS FOUND IN THE BASKET. THE PROCEDURE WAS COMPLETED WITH A 5% FINAL RESIDUAL IN LESION STENOSIS. THERE WERE NO MAJOR ADVERSE EVENTS ASSOCIATED WITH THE CORDIS' DEVICES. THE PT WAS ADMINISTERED ASPIRIN AND CLOPIDOGREL DURING PRE PROCEDURE AND AT DISCHARGE. THE PT WAS DISCHARGED THE FOLLOWING DAY WITH A NIH SCORE OF 1 AND A RANKIN STROKE SCALE SCORE OF 0 (NO CHANGE FROM BASELINE). A 30-DAY FOLLOW-UP WAS MADE AND THE PT WAS EVALUATED WITH NO CHANGE IN THE NIH STROKE SCALE SCORE OF 1 AND THE RANKIN STROKE SCALE SCORE OF 0, WITHOUT ADVERSE EVENTS AND ONGOING MEDICATIONS INCLUDED ASPIRIN AND CLOPIDOGREL. THE PT DIED 6 MONTHS POST STENT IMPLANT. THE DEATH WAS UNRELATED TO BOTH CORDIS PRODUCT(S) AND INDEX PROCEDURE. DURING THE INVESTIGATION THE CAUSE OF DEATH AND/OR THE DEATH CERTIFICATE WERE REQUESTED HOWEVER NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISE RX NITINOL STENT SELF EXPANDING STENTS (NIM) NIM CORDIS DE MEXICO NA 13235044

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Death ANGIOGUARD ((B)(6)).| ANGIOGUARD