BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1062879 · Received June 18, 2008

    Report

    Report Number
    9616099-2008-01548
    Event Type
    Injury
    Date Received
    June 18, 2008
    Date of Event
    January 29, 2008
    Report Date
    January 17, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT WAS RANDOMIZED TO THE CLINICAL TRIAL FOR THREE-VESSEL CORONARY ARTERY DISEASE. A STAGED PROCEDURE WAS PLANNED AT INDEX PROCEDURE. THE INDICATION FOR THE INDEX PROCEDURE WAS UNSTABLE ANGINA PECTORIS. THE TARGET LESION WAS THE MID LEFT ANTERIOR DESCENDING (LAD). THE VESSEL WAS DESCRIBED AS A NATIVE CORONARY ARTERY. REFERENCE VESSEL DIAMETER WAS 2.5MM AND LESION LENGTH WAS 15 MM. PRE AND POST PROCEDURE STENOSIS WAS 90 AND ZERO PERCENT, RESPECTIVELY. PRE AND POST PROCEDURE TIMI FLOW WAS II AND III. THE LESION WAS DESCRIBED AS DENOVO, WITH NO MAJOR SIDE BRANCH INVOLVEMENT, OF SMOOTH CONTOUR AND READILY ACCESSABLE AT PROXIMAL SEGMENT. ANGULATION WAS <45 DEGREES, CONCENTRIC, WITH LITTLE TO NO CALCIFICATION AND WITHOUT THROMBUS. LESION CLASSIFICATION WAS TYPE B1. A 6F GUIDING CATHETER WAS USED. THE LESION WAS PREDILATED WITH A 2.5 X 15MM BALLOON AT 12 ATMS, INFLATION TIME IS UNK. A 2.75 X 28 MM CYPHER SELECT PLUS STENT WAS DEPLOYED AT 12 ATMS WITH SATISFACTORY RESULTS. POST DILATATION WAS NOT CONDUCTED. INTRAVASCULAR ULTRASOUND (IVUS) WAS NOT PERFORMED. THE PT WAS DISCHARGED ON 75 MG CLOPIDOGREL FOR ONE MO AND ACE INHIBITORS. ASPIRIN WAS NOT PRESCRIBE DUE TO INTOLERANCE/ALLERGY. 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

    ADD'L INFO WAS REC'D FROM STUDY INDICATING THIS PT UNDERWENT A CABG PROCEDURE. TO DATE, THE PERTINENT SITE HAS NOT CLARIFIED IF THE CABG INVOLVED THE TARGET LESION. THEREFORE, THIS EVENT IS BEING REPORTED AS CORONARY ARTERY RESTENOSIS.

    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 13301302

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| L| R 6F GUIDING CATHETER| 2.5 X 15 MM BALLOON