BEUDAMED
    FDA Adverse Event Death Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1210664 · Received October 23, 2008

    Report

    Report Number
    9616099-2008-02511
    Event Type
    Death
    Date Received
    October 23, 2008
    Date of Event
    May 13, 2008
    Report Date
    October 13, 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
    HU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CYPHER SIROLIMUS-ELUTING CORONARY STENT IS DISTRIBUTED OUTSIDE OF THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE UNITED STATES CYPHER SIROLIMUS-ELUTING CORONARY STENT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    A PATIENT WAS ENROLLED IN THE STUDY IN 2008, WITH 2-VESSEL DISEASE. THE MAIN INDICATION FOR THE PROCEDURE WAS STABLE ANGINA PECTORIS. THREE MONTHS LATER, THE PATIENT EXPERIENCED A Q-WAVE, ANTERIOR, TARGET VESSEL RELATED TO MYOCARDIAL INFARCTION. PEAK CK WAS THREE TIMES ABOVE THE UPPER NORMAL LEVEL, TROPONIN WAS GREATER THAN OR EQUAL TO FIVE TIMES ABOVE THE UPPER NORMAL LEVEL AND PEAK CK-MB WAS NORMAL. IT WAS ALSO NOTED THAT THE PATIENT HAD A 90% OCCLUSION IN THE PROXIMAL LEFT ANTERIOR DESCENDING. THIS WAS TREATED WITH THE IMPLANT OF A 3.0 X 23MM CYPHER SELECT PLUS STENT. FIVE DAYS LATER, THE PATIENT SUDDENLY DIED. IT WAS REPORTED AS A CARDIAC DEATH. THERE WAS NO EVIDENCE FOR STENT THROMBOSIS OR MYOCARDIAL INFARCTION. THE TARGET LESION WAS A NATIVE, DE NOVO, OSTIAL, SMOOTH, READILY ACCESSIBLE, CONCENTRIC, TYPE B1 PROXIMAL TO MID LEFT ANTERIOR DESCENDING. THE REFERENCE VESSEL DIAMETER WAS 2.75MM AND THE LESION LENGTH WAS 16MM. PRE-PROCEDURE DIAMETER STENOSIS WAS 75%. THE LESION WAS PRE-DILATED WITH A 2.75 X 20MM BALLOON AT 14 ATM AND A 2.75 X 23MM CYPHER SELECT PLUS STENT WAS IMPLANTED AT 9ATM WITH SATISFACTORY RESULTS. THE STENT WAS IMPLANTED DUE TO A DISSECTION (UNKNOWN WIRE AND UNKNOWN BALLOON). THE STENT WAS NOT POST DILATED. POST-PROCEDURE DIAMETER STENOSIS WAS 0%. THE PATIENT'S PRE-PROCEDURE MEDICATIONS INCLUDED: ASPIRIN, STATINS, ACE INHIBITORS, BETA-BLOCKERS AND CLOPIDOGREL. THE PATIENT'S INTRA-PROCEDURE MEDICATIONS INCLUDED: ASPIRIN, HEPARIN AND CLOPIDOGREL. THE PATIENT'S POST-PROCEDURE MEDICATIONS INCLUDED: ASPIRIN, ACE INHIBITORS, INSULIN BETA-BLOCKERS AND CLOPIDOGREL.

    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 13285293

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death| H| L| R 6FR GUIDING CATHETER