BEUDAMED
    FDA Adverse Event Death Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 971669 · Received December 28, 2007

    Report

    Report Number
    9616099-2007-02628
    Event Type
    Death
    Date Received
    December 28, 2007
    Date of Event
    August 6, 2007
    Report Date
    December 13, 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
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS OUS CYPHER SELECT 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 UPON 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    A PATIENT WAS ENROLLED IN THE STUDY IN 2006 WITH 1-VESSEL DISEASE. THE MAIN INDICATION FOR THE INTERVENTION WAS UNSTABLE ANGINA PECTORIS. DURING A FOLLOW-UP VISIT, EIGHT MONTHS POST INDEX PROCEDURE, THE PATIENT COMPLAINED OF ANGINA PECTORIS. THE MEDICATION TREATMENT OF ASPIRIN, INSULIN, STATINS AND ACE INHIBITORS WAS ONGOING. HOWEVER, CLOPIDOGREL WAS STOPPED BECAUSE THE PATIENT HAD TO HAVE DENTAL SURGERY. AN ECG WAS DONE. THE ECG REVEALED THAT THE PATIENT EXPERIENCED A NON-Q WAVE MYOCARDIAL INFARCTION IN AN UNDETERMINED LOCATION. THERE WAS NO EVIDENCE OF STENT THROMBOSIS. IN ADDITION, IT WAS NOTED THAT THE PATIENT EXPERIENCED 60% DISTAL, PERI-STENT RESTENOSIS. THE NEXT DAY, THE LESION WAS TREATED WITH BALLOON DILATION ONLY. THAT SAME DAY THE PATIENT DIED FROM CONGESTIVE HEART FAILURE. THE LESION WAS IN THE POSTERIOR DESCENDING ARTERY. IT WAS TYPE C, NATIVE, DE NOVO, IRREGULAR, MODERATELY TORTUOUS AND ECCENTRIC. THE LESION HAD A REFERENCE VESSEL DIAMETER OF 2.27MM AND A LESION LENGTH OF 20MM. PRE-PROCEDURE DIAMETER STENOSIS WAS 78%. A 2.5 X 23MM CYPHER SELECT STENT WAS ELECTIVELY IMPLANTED AT 20ATM WITH SATISFACTORY RESULTS. THE STENT WAS NOT POST-DILATED. POST-PROCEDURE DIAMETER STENOSIS WAS 8%. THE PATIENT'S PRE-PROCEDURE MEDICATIONS INCLUDED: ASPIRIN, CLOPIDOGREL, STATINS, ACE INHIBITORS AND BETA-BLOCKERS. THE PATIENT'S INTRA-PROCEDURE MEDICATIONS INCLUDED: ASPIRIN AND HEPARIN. THE PATIENT'S POST-PROCEDURE MEDICATIONS INCLUDED: ASPIRIN, CLOPIDOGREL, INSULIN, STATINS, ACE INHIBITORS AND BETA-BLOCKERS.

    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 I0706003

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death A 6F GUIDING CATHETER WAS USED DURING THE| PROCEDURE.