BEUDAMED
    FDA Adverse Event Death Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1213930 · Received October 28, 2008

    Report

    Report Number
    9616099-2008-02541
    Event Type
    Death
    Date Received
    October 28, 2008
    Date of Event
    August 13, 2008
    Report Date
    October 8, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    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

    IN 2007, TWO CYPHER STENTS WERE PLACED IN THE PROXIMAL AND MID LAD. IT WAS AN ELECTIVE CASE. PRE-DILATION WAS CONDUCTED WITH A BALLOON (2.5/13MM) AT 12ATM FOR 5 SECONDS. THE FIRST CYPHER (2.5/23MM) WAS IMPLANTED AT THE DISTAL END OF THE LESION AT 18ATM FOR 10 SECONDS, AND A SECOND CYPHER (2.5/18MM) WAS IMPLANTED OVERLAPPING THE FIRST CYPHER AT 16ATM FOR 10 SECONDS. POST-DILATION WAS NOT CONDUCTED. IVUS WAS NOT CONDUCTED. THE RESIDUAL PERCENT OF STENOSIS WAS 0%. TIMI FLOW BEFORE THE PROCEDURE WAS 3, AND 3 AFTER THE PROCEDURE. ACT WAS NOT MEASURED. FOR THE DISTAL LAD, PRE-DILATION WAS CONDUCTED WITH A BALLOON (2.5/13MM) AT 8ATM. INFLATION TIME WAS UNKNOWN. A CYPHER (2.5/18MM) STENT WAS IMPLANTED AT 14ATM FOR 10 SECONDS. POST-DILATION WAS NOT CONDUCTED. IVUS WAS NOT CONDUCTED. THE RESIDUAL PERCENT OF STENOSIS WAS 0%. TIMI FLOW BEFORE THE PROCEDURE WAS 3, AND 3 AFTER THE PROCEDURE. ACT WAS NOT MEASURED. IN 2008, THE PT COMPLAINED OF CHEST PAIN AND DEVELOPED CARDIAC FAILURE. A THROMBOTIC EVENT HAD OCCURRED IN THE PROXIMAL AND MID LAD. ASPIRATION AND ADDITIONAL STENT PLACEMENT WAS PERFORMED. FIVE DAYS LATER, THE PT EXPIRED. PHYSICIAN'S COMMENT: THE POSSIBLE CAUSE OF THE THROMBOTIC EVENT WAS THAT THE PT MIGHT NOT HAVE BEEN PROPERLY TAKING THE ANTI-PLATELET MEDICATION. THE CAUSE OF THE DEATH WAS CARDIAC FAILURE AND ELECTRICAL STORM. THE PRODUCT IS NOT AVAILABLE FOR EVAL AND TESTING. ADDITIONAL INFO WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THIS DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE CYPHER CORONARY SDS/STENTS DISTRIBUTED IN THE UNITED STATES. PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF FIVE PRODUCTS INVOLVED WITH THIS EVENT WHICH IS ASSOCIATES WITH MFG. REPORT #9616099-2008-02539, 9616099-2008-02540, 9616099-2008-02543 AND 9616099-2008-02544.

    Description of Event or Problem · 1

    SEVENTEEN MONTHS AFTER HAVING FOUR CYPHER STENTS PLACED IN THE CORONARY ARTERIES, THE PT WAS BROUGHT TO THE HOSP COMPLAINING OF CHEST PAIN AND HAD DEVELOPED CARDIAC FAILURE. A CORONARY ANGIOGRAM (CAG) WAS PERFORMED AND REVEALED THROMBUS FROM THE PROXIMAL EDGE AND DISTALLY INSIDE THE IMPLANTED CYPHER AT THE PROXIMAL AND MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. TO TREAT THE THROMBUS, ASPIRATION WAS CONDUCTED, AND ANOTHER CYPHER (3.0/28MM) WAS IMPLANTED INSIDE THE PREVIOUSLY IMPLANTED CYPHERS. FIVE DAYS LATER, THE PT EXPIRED DUE TO CARDIAC FAILURE AND ELECTRICAL STORM (I.E. DEADLY HEART RHYTHM). THE PT WAS A MALE. THE TARGET LESIONS WERE THE PROXIMAL RIGHT CORONARY ARTERY (RCA), THE PROXIMAL AND MID LAD, AND THE DISTAL LAD. ALL THE LESIONS WERE DE NOVO. THE LESION AT THE RCA WAS ECCENTRIC. AHA/ACC CLASSIFICATION OF THE VESSEL WAS TYPE C. THE VESSEL LENGTH WAS 27MM, AND THE VESSEL DIAMETER WAS 3.5MM. THE LESION AT THE PROXIMAL AND MID LAD WAS ECCENTRIC, BIFURCATED AND FLEXED. AHA/ACC CLASSIFICATION OF THE VESSEL WAS TYPE C. THE VESSEL LENGTH WAS 44MM AND THE VESSEL DIAMETER WAS 2.5MM. THE LESION IN THE DISTAL LAD WAS CONCENTRIC. AHA/ACC CLASSIFICATION OF THE VESSEL WAS TYPE B1. THE VESSEL LENGTH WAS 15.5MM, AND THE VESSEL DIAMETER WAS 2.4MM. IN 2007, A CYPHER STENT WAS IMPLANTED IN THE RCA. IT WAS AN ELECTIVE CASE. PRE-DILATION WAS CONDUCTED WITH A BALLOON (2.5/15MM) AT 14ATM FOR 5SECONDS. THEN A CYPHER (3.5/23MM) WAS IMPLANTED AT 20ATM FOR 10SECONDS. POST-DILATION WAS NOT CONDUCTED. IVUS WAS NOT CONDUCTED. THE RESIDUAL PERCENT OF STENOSIS WAS 0%. TIMI FLOW BEFORE THE PROCEDURE WAS 2, AND 3 AFTER THE PROCEDURE. ACT WAS NOT MEASURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT (NIQ) NIQ CORDIS DE MEXICO NA I0107087

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death| H| R