BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1053098 · Received May 22, 2008

    Report

    Report Number
    9616099-2008-01376
    Event Type
    Injury
    Date Received
    May 22, 2008
    Date of Event
    March 30, 2008
    Report Date
    April 28, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PATIENT WAS RANDOMIZED TO THE REGISTRY ON FOR ONE-VESSEL DISEASE. A STAGED PROCEDURE WAS NOT PLANNED. THE INDICATION FOR THE INDEX PROCEDURE WAS AN ACUTE INTERIOR MYOCARDIAL INFARCTION <6H PRE PROCEDURE. THE TARGET VESSEL WAS THE PROXIMAL LAD. THE VESSEL WAS A NATIVE CORONARY ARTERY. REFERENCE VESSEL DIAMETER WAS 3.5MM. LESION LENGTH WAS 23MM. PRE-PROCEDURE DIAMETER STENOSIS WAS 100% AND POST PROCEDURE WAS ZERO PERCENT. TIMI FLOW PRE AND POST PROCEDURE WAS 0 AND III. THE LESION WAS A TOTALLY OCCLUDED, RESTENOTIC LESION PREVIOUSLY TREATED WITH AN UNKNOWN DRUG-ELUTING STENT. THERE WS NO MAJOR SIDE BRANCH INVOLVEMENT. THE LESION WAS SMOOTH AND READILY ACCESSIBLE AT PROXIMAL SEGMENT. THE LESION WAS CONCENTRIC WITH LITTLE TO NO CALCIFICATION. LESION CLASSIFICATION WAS TYPE C. A 6F- GUIDING CATHETER WAS USED. PREDILATATION WAS PERFORMED USING A 2.0 X 20MM BALLOON AT 20 ATMS. A CYPHER WAS DEPLOYED AT 18 ATMS WITH SATISFACTORILY RESULTS. POST DILATATION WAS NOT PERFORMED. IVUS WAS NOT USED. THE PATIENT WAS DISCHARGED ON 100MG ASPIRIN, 75MG CLOPIDOGREL, STATINS, ACE-INHIBITORS AND BETA-BLOCKERS. PLEASE NOTE: DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE UNITED STATES PRODUCT. ANY ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED INDICATING THAT FOLLOWING THE INDEX PROCEDURE, THE PATIENT EXPERIENCED AN ANTERIOR Q-WAVE MYOCARDIAL INFARCTION (MI). FOLLOWING THE INDEX PROCEDURE PEAK CK WAS >5 TIMES ABOVE UPPER NORMAL LEVEL (UNL), PEAK CK-MB WAS >5 TIMES ABOVE UNL AND TROPONIN T WAS >5 TIMES ABOVE UNL. THE MI WAS TARGET VESSEL RELATED. THERE WAS NO EVIDENCE OF STENT THROMBOSIS AND RE-PCI WAS NOT REQUIRED. THIS EVENT WAS REPORTED AS UNRELATED TO THE CORDIS STENT AND THE INDEX PROCEDURE. THE REGISTRY ALSO STATED THAT THIS PATIENT WAS ADMITTED WITH AN ST ELEVATION MYOCARDIAL INFARCTION. THE CHEST PAIN STARTED 2 HOURS BEFORE ARRIVAL TO THE PCI CENTER. THE CORONARY ANGIOGRAPHY SHOWED A STENT THROMBOSIS IN THE PROXIMAL LAD. THIS STENT WAS IMPLANTED AT ANOTHER LOCATION IN 2006 AND DOCUMENTATION IS NOT AVAILABLE. THE PATIENT HAD STOPPED TAKING CLOPIDOGREL AND ASPIRING TREATMENT ONE YEAR AGO. THE OCCLUDED LAD WAS SUCCESSFULLY OPENED WITH BALLOON AND A CYPHER SELECT STENT. THE ELEVATION OF CARDIAC ENZYMES (CARDIAC NECROENZYMES, CK, CK-MB, AND TROPONIN T) WAS RECORDED. AT DISCHARGE THE PATIENT HAD SLIGHTLY ELEVATED CK-MB LEVEL AND MODERATE LEFT VENTRICULAR EJECTION FRACTION AND WAS WITHOUT ANY COMPLAINT.

    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 13343278

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization| L| R A 6F-GUIDING CATHETER| A 2.0X20MM BALLOON