BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1021194 · Received March 28, 2008

    Report

    Report Number
    9616099-2008-00817
    Event Type
    Injury
    Date Received
    March 28, 2008
    Date of Event
    January 16, 2008
    Report Date
    March 20, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    APPROX TWO MONTHS LATER, DURING THE SIX-MONTHS FOLLOW UP, THE PT ALSO REPORTED HAVING CHEST PAIN. THIS CYPHER SIROLIMUS-ELUTING CORONARY STENT IS DISTRIBUTED OUTSIDE OF THE US. HOWEVER, IT IS SIMILAR TO THE US CYPHER SIROLIMUS-ELUTING CORONARY STENT. ADD'L INFO WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE CORDIS CLINICAL REGISTRY IN ANOTHER COUNTRY INDICATED A PT HAD AN EPISODE OF MYOCARDIAL INFARCTION FIVE MONTHS AFTER RECEIVING A CYPHER STENT. THE PT ALSO HAD AN EPISODE OF ANGINA APPROX TWO MONTHS LATER. THE MAIN INDICATION FOR THE INDEX PROCEDURE WAS AN UNDETERMINED NON-ST ELEVATION ACUTE MYOCARDIAL INFARCTION BETWEEN 24 TO 72 HRS PRIOR TO THE PROCEDURE. A 2.25 X 28MM CYPHER STENT WAS IMPLANTED AT 14 ATMS IN THE MID RIGHT CORONARY ARTERY TO TREAT A LESION DESCRIBED AS 1.85 X 14MM LONG, DE NOVO AND IRREGULAR WITH MODERATE TORTUOUSITY, LITTLE OR NO CALCIFICATION, A 45 DEGREE TO 90 DEGREE ANGULATION, CONCENTRIC WITH A TYPE B2 CLASSIFICATION AND 79% STENOSIS. PREDILATATION WAS CONDUCTED WITH AN UNK 2.5 X 20MM BALLOON AT 6 ATMS. POST DILATATION WAS ALSO CONDUCTED WITH AN UNK 2.75 X 12MM BALLOON AT 14 ATMS. NO PROCEDURAL COMPLICATIONS WERE REPORTED AND THE PT WAS DISCHARGED THE FOLLOWING DAY. FIVE MONTHS LATER, AN INFERIOR WALL Q-WAVE MYOCARDIAL INFARCTION WAS DIAGNOSED AFTER CHEST PAIN FOR 6 HRS. THE PT EXHIBITED ST ELEVATION IN THE INFERIOR WALL LEADS AND A RECIPROCAL LATERAL DEPRESSION. THERE WAS NOT PRIMARY TREATMENT. THE EVENT WAS DETERMINED AS UNRELATED TO THE CYPHER STENT AND UNRELATED TO THE 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 13233423

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR CLOPIDOGREL| STATINS| ASPIRIN| ORAL ANTIDIABETICS| ACE INHIBITORS| BETA-BLOCKERS