BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1021290 · Received March 25, 2008

    Report

    Report Number
    9616099-2008-00787
    Event Type
    Injury
    Date Received
    March 25, 2008
    Date of Event
    October 30, 2007
    Report Date
    March 4, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CYPHER STENT DELIVERY SYSTEM IS DISTRIBUTED OUTSIDE OF THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE UNITED STATES CYPHER STENT DELIVERY SYSTEM. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE CORDIS CLINICAL STUDY REGISTRY INDICATED THAT A PATIENT HAD 80% STENOSIS AND A TIMI FLOW OF I IN A VESSEL THAT WAS STENTED WITH A CYPHER STENT TWENTY-SEVEN DAYS EARLIER. THE MAIN INDICATION FOR THE INDEX PROCEDURE WAS ACUTE NSTEMI ANTERIOR MYOCARDIAL INFARCTION BETWEEN 24 TO 72 HOURS. A 2.5 X 33 MM CYPHER STENT WAS DEPLOYED AT 20 ATM IN THE PROXIMAL LEFT ANTERIOR DESCENDING CORONARY ARTERY (LAD) TO TREAT A LESION DESCRIBED A 2.5 X 25MM, DE NOVO, ECCENTRIC, A TYPE C CLASSIFICATION AND TOTAL OCCLUSION GREATER THAN THREE MONTHS. THE VESSEL WAS PREDILATED AT 14 ATMS WITH AN UNKNOWN 2.4 X 15 MM BALLOON. NO PROCEDURAL COMPLICATION WAS REPORTED AND THE PATIENT WAS DISCHARGED HOME ON ASPIRIN, CLOPIDOGREL, STATINS, BETA-BLOCKERS AND INSULIN. A STAGED PROCEDURE FOR THE DISTAL RIGHT CORONARY ARTERY (RCA) WAS PLANED FOR LATER FOR CARDIOVASCULAR SAFETY. WHEN THE PATIENT RETURNED TWENTY-SEVEN DAYS LATER FOR THE STAGED PROCEDURE, CORONARY ANGIOGRAM REVEALED AN 80% STENOSIS OF THE PREVIOUSLY STENTED PROXIMAL LAD. IT IS NOT KNOWN IF THE STENOSIS WAS TREATED BUT THE RCA WAS TREATED WITH A XIENCE 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 13249110

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR INSULIN| ASPIRIN| STATINS| BETA BLOCKERS| CLOPIDOGREL