BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1032332 · Received April 21, 2008

    Report

    Report Number
    9616099-2008-01039
    Event Type
    Injury
    Date Received
    April 21, 2008
    Date of Event
    January 5, 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
    GM
    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. ADDITIONAL INFO WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED INDICATED THE PT HAD AN EPISODE OF RESTENOSIS SIX MONTHS AFTER RECEIVING A CYPHER STENT IN THE MID CIRCUMFLEX CORONARY ARTERY. THE TARGET VESSEL HAD PREVIOUSLY BEEN VASCULARIZED THREE YEARS PRIOR TO THE INDEX PROCEDURE. THE MAIN INDICATION FOR THE INDEX PROCEDURE WAS STABLE ANGINA AND POSITIVE STRESS TEST. A 2.5 X 18MM CYPHER STENT WAS IMPLANTED AT 16 ATMS IN THE MID CIRCUMFLEX DESCRIBED AS 2.5 X 15MM LONG, DE NOVO, MODERATE TORTUOSITY, ANGULATION EQUAL TO OR GREATER THAN 45 DEGREES BUT LESS 90 DEGREES, ECCENTRIC WITH A TYPE C CLASSIFICATION AND 80% STENOSIS. THERE WAS NO RESIDUAL STENOSIS AND THE TIMI FLOW WAS THREE BEFORE AND AFTER THE PROCEDURE. NO PROCEDURAL COMPLICATION WAS REPORTED; THE PT WAS DISCHARGED THE FOLLOWING DAY ON ASPIRIN, CLOPIDOGREL, STATINS AND ACE INHIBITORS. THE PT REMAINED ASYMPTOMATIC AT THE ONE-MONTH AND SIX-MONTH FOLLOW-UP. BUT A ROUTINE SIX-MONTH FOLLOW UP CORONARY ANGIOGRAM REVELED A STENOSIS OF THE FIRST OBTUSE MARGINAL BRANCH, WHICH WAS ATTRIBUTED TO THE STENT IN THE MID CIRCUMFLEX. THE STENOSIS WAS TREATED BY BALLOON ANGIOPLASTY WITH GOOD RESULTS.

    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 13205130

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention ACE INHIBITORS| CLOPIDOGREL| ASPIRIN| STATINS