BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1062880 · Received June 18, 2008

    Report

    Report Number
    9616099-2008-01549
    Event Type
    Injury
    Date Received
    June 18, 2008
    Date of Event
    April 15, 2008
    Report Date
    May 28, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE: DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE UNITED STATES PROD. ANY ADD'L INFO WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THIS PT WAS RANDOMIZED TO THE REGISTRY ON FOR TWO-VESSEL DISEASE. THE INDICATION FOR THE INDEX PROCEDURE WAS SILENT ISCHEMIA. FOLLOWING THE INDEX PROCEDURE, TROPONIN WAS >5 TIMES ABOVE UPPER NORMAL LEVEL. THE STUDY INDICATED THE PT EXPERIENCED A TARGET VESSEL RELATED NON-Q WAVE MYOCARDIAL INFARCTION. THERE WAS NO EVIDENCE OF STENT THROMBOSIS AND RE-PCI WAS NOT REQUIRED. THE SITE INDICATED ECG RESULTS DID NOT PRESENT CHANGES IN COMPARISON WITH PREVIOUS REPORTS. THIS EVENT WAS REPORTED AS UNRELATED TO THE CORDIS DEVICES AND RELATED TO THE INDEX PROCEDURE. FOLLOWING THE INDEX PROCEDURE, THE PT ALSO DEVELOPED AN ALLERGIC REACTION (SKIN RASH). THE EVENT WAS RESOLVED WITHOUT SEQUEL. THIS EVENT WAS REPORTED AS UNRELATED TO THE CORDIS DEVICES.

    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 13206779

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization 3 X 20MM BALLOON