BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1031093 · Received April 17, 2008

    Report

    Report Number
    9616099-2008-01024
    Event Type
    Injury
    Date Received
    April 17, 2008
    Date of Event
    February 27, 2008
    Report Date
    March 25, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PT WAS RANDOMIZED TO THE REGISTRY FOR ONE-VESSEL DISEASE. A STAGED PROCEDURE WAS NOT PLANNED. THE INDICATION FOR THE INDEX PROCEDURE WAS STABLE ANGINA PECTORIS. THE TARGET LESION WAS THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD). PRE-PROCEDURE DIAMETER STENOSIS WAS 80% AND POST PROCEDURE WAS ZERO PERCENT. TIMI FLOW PRE AND POST PROCEDURE IS UNK. THE LESION WAS DENOVO AND CLASSIFIED AS TYPE B1. PREDILATATION WAS PERFORMED USING A 2.0X8MM BALLOON AT 14 ATMS. A CYPHER WAS DEPLOYED AT 14 ATMS WITH SATISFACTORY RESULTS. DUE TO STENTS UNDER EXPANSION, POST DILATATION WAS PERFORMED USING A 2.5 X 8MM BALLOON AT 20 ATMS. IVUS WAS NOT USED. THE PT WAS DISCHARGED TWO DAYS LATER ON 100MG ASPIRIN FOR 12 MONTHS, 75MG CLOPIDOGREL, STATINS, ACE-INHIBITORS, AND BETA-BLOCKERS. DURING THE ONE MONTH FOLLOW-UP, THE PT WAS ASYMPTOMATIC AND COMPLIANT WITH ANTI-PLATELET REGIMEN. PLEASE NOTE: DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE UNITED STATES PRODUCT. ANY ADD'L INFO WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE REGISTRY INDICATES THAT FOLLOWING THE INDEX PROCEDURE, CARDIAC ENZYMES WERE ELEVATED. AT 6-24TH PEAK CK WAS 2 TIMES ABOVE UPPER NORMAL LEVEL (UNL), AND TROPONIN WAS >5 TIMES ABOVE UNL. AT 24H-DISCHARGE, PEAK CK WAS <2 TIMES ABOVE UNL AND TROPONIN REMAINED AT >5 TIMES UNL. THE DAY AFTER, THE PT WAS DIAGNOSED WITH A NON-Q WAVE MYOCARDIAL INFARCTION (MI). TROPONIN INCREASED TO 3 TIMES ABOVE UNL. THE MI LOCATION AND TARGET VESSEL INVOLVEMENT WAS UNDETERMINED. THERE WAS NO EVIDENCE OF THROMBOSIS AND REVASCULARIZATION WAS NOT REQUIRED. THE PT WAS DISCHARGED THE FOLLOWING DAY AND NO FURTHER ACTION WAS TAKEN. THE RELATIONSHIP TO THE CORDIS STENT AND INDEX PROCEDURE WAS REPORTED AS POSSIBLE.

    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 13328038

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization 2.0X8MM BALLOON| 2.5X8MM BALLOON| 6F GUIDING CATHETER| (2) BMW GUIDE WIRE