BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1040527 · Received May 9, 2008

    Report

    Report Number
    9616099-2008-01277
    Event Type
    Injury
    Date Received
    May 9, 2008
    Date of Event
    March 5, 2008
    Report Date
    April 20, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TARGET LESION WAS THE MID RCA. THE VESSEL WAS A NATIVE CORONARY ARTERY. REFERENCE VESSEL DIAMETER WAS 3.5MM AND LESION LENGTH WAS 25MM. THE LESION WAS DE NOVO, WITH NO MAJOR SIDE-BRANCH INVOLVEMENT. LESION CLASSIFICATION WAS TYPE C. PREDILATATION WAS PERFORMED USING A 2.0X12MM BALLOON AT 14 ATMS. A 7F-GUIDING CATHETER AND RUN-THROUGH GUIDE WIRE WERE ALSO USED. A STENT WAS DEPLOYED AT 14 ATMS. DUE TO STENT UNDER EXPANSION POST DILATATION WAS PERFORMED USING A 4.0X15MM BALLOON AT 20 ATMS. IVUS WAS NOT USED. THE SECOND TARGET LESION WAS THE PROXIMAL TO MID LAD. THE VESSEL WAS A NATIVE CORONARY ARTERY. REFERENCE VESSEL DIAMETER WAS 3.0MM AND LESION LENGTH WAS 45MM. THE LESION WAS DENOVO, BIFURCATION, AND A TOTAL OCCLUSION. LESION CLASSIFICATION WAS TYPE C. PREDILATATION WAS PERFORMED USING A 2.0X12MM BALLOON AT 20 ATMS. A 7F-GUIDING CATHETER AND TWO RUN-THROUGH GUIDE WIRES WERE ALSO USED. TWO CYPHER STENTS WERE IMPLANTED OVERLAPPING EACH OTHER. THE FIRST STENT WAS A SECOND STENT DEPLOYED AT 14 ATMS. DUE TO STENT UNDER EXPANSION POST DILATATION WAS PERFORMED USING A 3.5X15MM BALLOON AT 16 ATMS. THIS WAS FOLLOWED BY DEPLOYMENT OF A THIRD STENT AT 14 ATMS. DUE TO STENT UNDER EXPANSION POST DILATATION WAS PERFORMED USING A 3.5X15MM BALLOON AT 20 ATMS. IVUS WAS NOT USED. THE THIRD TARGET LESION WAS THE MID CIRCUMFLEX. THE VESSEL WAS A NATIVE CORONARY ARTERY. REFERENCE VESSEL DIAMETER WAS 2.5MM AND LESION LENGTH WAS 20MM. THE LESION WAS DENOVO, WITH NO MAJOR SIDE-BRANCH INVOLVEMENT. LESION CLASSIFICATION WAS TYPE B2. PREDILATATION WAS NOT PERFORMED. A 7F-GUIDING CATHETER AND A BMW-J GUIDE WIRE WERE ALSO USED. A CRB23250 WAS DEPLOYED AT 14 ATMS. DUE TO STENT UNDER EXPANSION POST DILATATION WAS PERFORMED USING A 2.75X15MM BALLOON AT 20 ATMS. IVUS WAS NOT USED. THE PT WAS DISCHARGED ON 100MG ASPIRIN, 75MG CLOPIDOGREL, STATINS, INSULIN, LIPID LOWERING DRUGS, ACE-INHIBITORS AND BETA-BLOCKERS. THIS IS ONE OF FOUR PRODUCTS BEING REPORTED FOR THE SAME EVENT. PLEASE REFERENCE MANUFACTURING REPORTS#: 9616099-2008-01275, 9616099-2008-01276, 9616099-2008-01277, AND 9616099-2008-01278. PLEASE NOTE: DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE UNITED STATES PRODUCT. ANY ADD'L INFO WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED INDICATES THAT THE PT EXPERIENCED A NON Q-WAVE MYOCARDIAL INFARCTION FOLLOWING THE INDEX PROCEDURE. POST PROCEDURE CARDIAC ENZYMES WERE ELEVATED. AT 6-24H, PEACK CK WAS <2 TIMES ABOVE UPPER NORMAL LEVEL (UNI), PEAK CK-MB WAS 3 TIMES ABOVE UNI AND TROPONIN WAS 3 TIMES ABOVE UNI. THERE WAS NO EVIDENCE OF STENT THROMBOSIS AND RE-PCI WAS NOT REQUIRED. THE LOCATION OF THE MI WAS UNDETERMINED. THERE WERE NO ECG FINDINGS. THIS EVENT WAS REPORTED AS UNLIKELY RELATED TO THE INDEX DEVICES, AND POSSIBLE RELATED TO THE INDEX PROCEDURE.

    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 13312645

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization RUN-THROUGH GUIDE WIRES| BMW-J GUIDE WIRE| CYPHER STENT| 7F-GUIDING CATHETER| 3.5X15MM BALLOON| CYPHER STENT| 2.0X12MM BALLOON| CYPHER STENT| 2.75X15MM BALLOON| 4.0X15MM BALLOON