BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1032310 · Received April 21, 2008

    Report

    Report Number
    9616099-2008-01033
    Event Type
    Injury
    Date Received
    April 21, 2008
    Date of Event
    March 20, 2008
    Report Date
    March 26, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    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 THIRTY DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM (B)(4) CLINICAL STUDY REGISTRY INDICATED THE PT HAD A THROMBOTIC EVENT AND A MYOCARDIAL INFARCTION AFTER RECEIVING A CYPHER STENT IN THE BODY OF A SAPHENOUS VEIN GRAFT WITH THE CLOSET DISTAL ANASTOMOSIS TO SEGMENT 12, THE FIRST OBTUSE MARGIN. THE MAIN INDICATION FOR THE PROCEDURE WAS UNSTABLE ANGINA AND RESTING ECG CHANGES. THE TARGET LESION WAS IN THE BODY OF THE SAPHENOUS VEIN GRAFT; DESCRIBED AS 3.5 X 23MM LONG, DE NOVO, CONCENTRIC WITH A TYPE B2 CLASSIFICATION AND 80% STENOSIS. A 2.5 X 23MM CYPHER STENT WAS IMPLANTED FOR A 0% STENOSIS. PRE AND POST DILATATION WAS NOT CONDUCTED. THE FOLLOWING DAY A MYOCARDIAL INFARCTION WAS REPORTED AND THE PT WAS TREATED WITH BALLOON ANGIOPLASTY FOR A THROMBUS IN THE CYPHER STENT.

    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 13344651

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention CLOPIDOGREL| ASPIRIN