BEUDAMED
    FDA Adverse Event Death Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 897117 · Received August 10, 2007

    Report

    Report Number
    9616099-2007-01545
    Event Type
    Death
    Date Received
    August 10, 2007
    Date of Event
    February 16, 2004
    Report Date
    October 23, 2006
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PATIENT WAS RANDOMIZED TO THE CLINICAL STUDY IN 2004. AT INDEX PROCEDURE, THE PATIENTS RECEIVED A TOTAL OF TWO CYPHER SIROLIMUS-ELUTING CORONARY STENTS IMPLANTED AT THE CIRCUMFLEX AND 2ND OBTUSE MARGINAL. PER THE CLINICAL SITE, THE CRITICAL EVENT COMMITTEE (CEC) OF THE STUDY ADJUDICATED THE REPORTED ADVERSE EVENTS AS FOLLOWS: CEC DETERMINATION FOR AMI NON-Q: HIGHLY PROBABLE RELATED TO THE DEVICE AND INDEX PROCEDURE. CEC DETERMINATION FOR STENT THROMBUS: HIGHLY PROBABLE RELATED TO THE DEVICE AND INDEX PROCEDURE. CEC DETERMINATION FOR RE-PTCA OF TARGET LESION/SEVERE MACE: HIGHLY PROBABLE RELATED TO THE DEVICE AND INDEX PROCEDURE. CEC DETERMINATION FOR CARDIOGENIC SHOCK DUE TO PULMONARY EDEMA AND RESPIRATORY FAILURE: SEVERE ADVERSE EVENT HIGHLY PROBABLE RELATED TO THE DEVICE AND INDEX PROCEDURE. ALSO RELATED TO PATIENT'S PRIOR CONDITIONS. CEC DETERMINATION FOR DEATH: SEVERE ADVERSE EVENT HIGHLY PROBABLE RELATED TO THE DEVICE AND INDEX PROCEDURE. ALSO RELATED TO PATIENT'S PRIOR CONDITIONS. CEC DETERMINATION FOR ENZYMATIC INCREASE: NOT AN EVENT (INSIGNIFICANT ELEVATION OF CARDIAC ENZYMES). THIS FILE HAS BEEN RE-ACCESS AS PER THE SIMILAR DEVICE REPORTABILITY CRITERIA IMPLEMENTED BY CORDIS CORPORATION IN 2006. THE MDR DETERMINATION HAS CHANGED FROM NOT REPORTABLE EVENT, AS THE DEVICE IS CONSIDERED TO BE SIMILAR TO THE UNITED STATES PRODUCT CYPHER SIROLIMUS-ELUTING CORONARY STENT. PLEASE NOTE: DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE UNITED STATES PRODUCT. THIS IS ONE OF TWO PRODUCTS BEING REPORTED FOR THE SAME EVENT. PLEASE REFERENCE MANUFACTURING REPORTS #: 9616099-2007-01545 AND 9616099-2007-01547. ANY ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM THE CLINICAL STUDY INDICATING THAT THIS PATIENT EXPERIENCED SEVERAL ADVERSE EVENTS LISTED BELOW AND ULTIMATELY EXPIRED. THE CAUSE OF DEATH WAS REPORTED AS CARDIAC. HOWEVER, AN AUTOPSY WAS NOT DONE AND THE DEATH CERTIFICATE IS NOT AVAILABLE. IN ADDITION, A RELATIONSHIP OF THESE EVENTS TO THE INDEX PROCEDURE AND DEVICE WAS NOT PROVIDED AT THE TIME THESE REPORTS WERE RECEIVED. ADVERSE EVENTS REPORTED IN 2006: IN 2004: CHEST PAIN, MYOCARDIAL INFARCTION AT AN UNIDENTIFIABLE SITE. THE SAME DAY: SUB-ACUTE THROMBOTIC EVENT AND REVASCULARIZATION OF TARGET LESION. THE TARGET LESION WAS TOTALLY OCCLUDED; TIMI WAS ZERO, AND THE EVENT WAS TREATED WITH REVASCULARIZATION. APPROX ONE AND A HALF MONTHS LATER: RESPIRATORY FAILURE. THE PATIENT WAS INTUBATED AND THE EVENT EVENTUALLY RESOLVED. THE FOLLOWING MONTH: THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT NIQ CORDIS DE MEXICO NA R1203403

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death| H| L