BEUDAMED
    FDA Adverse Event Death Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 983896 · Received January 23, 2008

    Report

    Report Number
    9616099-2008-00200
    Event Type
    Death
    Date Received
    January 23, 2008
    Date of Event
    December 21, 2007
    Report Date
    December 27, 2007
    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

    THE PHYSICIAN'S COMMENTS REGARDING THE DEATH AND THROMBOTIC EVENT WAS THAT IT MAY BE DUE TO THE PT'S BLOOD CLOTTING ABNORMALITY BECAUSE THE PT REPEATEDLY EXPERIENCED THROMBUS EVEN IN THE FEMORAL ARTERY WHILE INSERTING THE IABP AND IS NOT RELATED TO A PROBLEM WITH THE CYPHER STENTS. THE PT'S INDEX PROCEDURE FOR CYPHER STENTING WAS AN ELECTIVE CASE. THE TARGET LESION WAS THE PROXIMAL CIRCUMFLEX/FIRST OBTUSE MARGINAL (OM). THE LESION WAS REPORTED TO BE: DE NOVO, CONCENTRIC, A BIFURCATION LESION, 60MM LENGTH, 2.5MM VESSEL DIAMETER, AND TYPE C. THE LESION WAS PRE-DILATED WITH A 2.5X20MM BALLOON AT 10ATM FOR 30 SEC. A CYPHER 2.5X18MM STENT (STENT #1) WAS IMPLANTED AT 14 ATM FOR 30 SEC. A 2.5X28MM STENT (STENT #2) WAS IMPLANTED AT 14ATM FOR 30 SEC PROXIMAL THE FIRST STENT. A CYPHER 2.5X23MM STENT (STENT #3) WAS IMPLANTED AT 14ATM FOR 30 SEC PROXIMAL TO STENT #2. ALL THREE STENTS WERE IMPLANTED IN OVERLAPPING FASHION. THE STENTS WERE POST-DILATED WITH A 2.5X20MM BALLOON AT 14ATM FOR 30 SEC. THE FLOW PRE AND POST-PROCEDURE WAS TIMI 3. IVUS WAS NOT DONE. THE RESIDUAL STENOSIS WAS 0%. AN ACT WAS NOT MEASURED. PLEASE NOTE THAT DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES, HOWEVER, IT IS SIMILAR TO THE UNITED STATES PRODUCT. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFO WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THIS IS ONE OF THREE PRODUCTS USED DURING THE SAME PROCEDURE. PLEASE REFERENCE MFR. REPORT #9616099-2008-00198, #9616099-2008-00199, AND #9616099-2008-00200.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT A PT WITH A HISTORY OF A PREVIOUS THROMBOTIC EVENT AFTER BARE METAL STENT (BMS) IMPLANTATION THAT REQUIRED CORONARY ARTERY BYPASS GRAFT (CABG) SURGERY, EXPERIENCED CHEST PAIN AND WAS UNSTABLE. THE TARGET LESION FOR THE BMS IMPLANTATION WAS THE LEFT CIRCUMFLEX. NO ADD'L INFO WAS AVAILABLE REGARDING THIS PROCEDURE/EVENT. SIX (6) DAYS AFTER THE REPORTED CHEST PAIN, THE PT HAD AN ELECTIVE PROCEDURE TO TREAT THE PROXIMAL CIRCUMFLEX/FIRST OBTUSE MARGINAL (OM) TARGET LESION. A FEW HOURS AFTER IMPLANTATION OF THREE (3) CYPHER STENTS, THE PT COMPLAINED OF CHEST PAIN. CORONARY ANGIOGRAPHY WAS DONE AND THROMBUS WAS OBSERVED PROXIMALLY IN THE PREVIOUSLY IMPLANTED CYPHER STENTS. THE ACUTE THROMBOSIS WAS TREATED BY BALLOON ANGIOPLASTY AND ASPIRATION OF THE THROMBUS. AN INTRA AORTIC BALLOON PUMP (IABP) WAS INSERTED. THE PT WAS REPORTED TO HAVE DEVELOPED AN ACUTE MYOCARDIAL INFARCTION (AMI). A BALLOON CATHETER (NON-CORDIS PRODUCT) WAS INSERTED TO TREAT THE AMI, BUT A DISSECTION OCCURRED. AT THE SAME TIME, THROMBUS WAS OBSERVED IN THE FEMORAL ARTERY AND WAS TREATED WITH AN UNK BMS. THE FLOW WAS REPORTED TO HAVE RECOVERED. IT WAS NOT KNOWN WHAT WAS DONE TO TREAT THE DISSECTION. THE PT'S CONDITION DID NOT CHANGE AND THE PT EXPIRED TWO DAYS LATER.

    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 13302059

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death| H| L| R 2.5X20MM BALLOON