BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1040302 · Received May 7, 2008

    Report

    Report Number
    9616099-2008-01248
    Event Type
    Injury
    Date Received
    May 7, 2008
    Date of Event
    February 25, 2008
    Report Date
    April 11, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CYPHER SIROLIMUS-ELUTING CORONARY STENT IS DISTRIBUTED OUTSIDE OF THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE UNITED STATES CYPHER SIROLIMUS-ELUTING CORONARY STENT. ADD'L INFO WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE PT WAS ADMITTED INTO THE HOSP IN 2008 DUE TO AN ACUTE MYOCARDIAL INFARCTION. THE TARGET LESION WAS A DE NOVO, THROMBOTIC TOTALLY OCCLUDED, TYPE C PROXIMAL LEFT ANTERIOR DESCENDING. THE LESION LENGTH WAS 21.5 MM AND THE VESSEL DIAMETER WAS 3.0 MM. THE LESION WAS DIRECT STENTED WITH A 3.0 X 23 MM CYPHER, WHICH WAS IMPLANTED AT 16 ATM FOR 30 SECONDS. IT WAS NOTED THAT THE STENT WAS UNDER-DILATED. THE LESION WAS POST-DILATED WITH A BALLOON AT 16 ATM FOR 30 SECONDS. RESIDUAL STENOSIS WAS 0%. ELEVEN DAYS LATER, THE PT RETURNED TO THE HOSP FOR A PERCUTANEOUS CORONARY INTERVENTION OF ANOTHER LESION. THE PT WAS NOT SHOWING ANY SYMPTOMS. CORONARY ANGIOGRAPHY WAS CONDUCTED AND THROMBUS WAS OBSERVED IN THE CYPHER ORIGINALLY IMPLANTED IN THE PROXIMAL LEFT ANTERIOR DESCENDING LESION. TO TREAT THE THROMBUS, ASPIRATION AND BALLOON ANGIOPLASTY WERE CONDUCTED. THE PT ALSO HAD AN INTRA AORTIC BALLOON PUMP INSERTED. THE PT WAS TAKEN TO ANOTHER HOSPITAL, BECAUSE HE HAD TO UNDERGO A CORONARY ARTERY BYPASS GRAFT. PER THE PHYSICIAN IT IS POSSIBLE THAT THE THROMBOTIC EVENT WAS CAUSED BECAUSE NO PRE-MEDICATION WAS GIVEN DUE THE FACT THAT THIS WAS AN EMERGENT CASE. ALSO, THE STENT WAS UNDER-DILATED AND THE PT MAY NOT HAVE TAKEN THEIR ANTI-PLATELET MEDICATION CORRECTLY.

    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 13320819

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| L| R 3.0 X 23 MM BALLOON