BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1061389 · Received June 16, 2008

    Report

    Report Number
    9616099-2008-01517
    Event Type
    Injury
    Date Received
    June 16, 2008
    Date of Event
    May 26, 2008
    Report Date
    May 26, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PATIENT WAS RANDOMIZED TO THE E-SELECT REGISTRY FOR THREE-VESSEL DISEASE. A STAGED PROCEDURE WAS NOT PLANNED. THE INDICATION FOR THE PROCEDURE WAS UNSTABLE ANGINA PECTORIS. THE FIRST TARGET LESION EXTENDED FROM THE LEFT MAIN (PROTECTED) TO MID LAD TO FIRST DIAGONAL BRANCH. THE VESSEL WAS A NATIVE CORONARY ARTERY. REFERENCE VESSEL DIAMETER WAS 2.5MM AND LESION LENGTH WAS 21MM. PRE-PROCEDURE DIAMETER STENOSIS WAS 80% AND ZERO PERCENT POST PROCEDURE. TIMI FLOW PRE AND POST PROCEDURE IS UNKNOWN. THE LESION WAS DENOVO, AND LESION CLASSIFICATION WAS TYPE C. PREDILATION WAS PERFORMED USING A 2.5X20MM BALLOON AT 14 ATMS. TWO CYPHER SELECT STENTS WERE DEPLOYED OVERLAPPING EACH OTHER. THE FIRST STENT WAS DEPLOYED AT 5ATMS. DUE TO STENT UNDER EXPANSION, POST DILATATION WAS PERFORMED USING A 3.0X28MM BALLOON AT 18 ATMS. THE SECOND STENT WAS DEPLOYED AT 20 ATMS. DUE TO STENT UNDER EXPANSION, POST DILATATION WAS PERFORMED USING A 3.5X20MM BALLOON AT 17 ATMS. IVUS WAS NOT USED. THE SECOND TARGET LESION WAS AT THE FIRST DIAGONAL BRANCH. THE VESSEL WAS A NATIVE CORONARY ARTERY. TWO STENTS WERE DEPLOYED, HOWEVER, PROCEDURAL DETAILS FOR THIS VESSEL WERE NOT PROVIDED. THE PATIENT WAS DISCHARGED ON 80MG ASPIRIN, 75MG CLOPIDOGREL, STATINS, AND BETA-BLOCKERS. AT ONE OF SIX MONTH FOLLOW-UP THE PATIENT WAS ASYMPTOMATIC AND COMPLIANT WITH ANTIPLATELET REGIMEN. THE PRODUCT REMAINS IMPLANTED IN THE PATIENT THUS NOT AVAILABLE FOR EVALUATION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. THIS IS ONE OF FOUR PRODUCTS BEING REPORTED FOR THE SAME EVENT. PLEASE REFERENCE MANUFACTURING REPORTS #: 9616099-2008-01516, 9616099-2008-01517, 9616099-2008-01518 AND 9616099-2008-01519.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM THE REGISTRY INDICATING THERE WAS AN INCREASE IN CARDIAC ENZYMES POST INDEX PROCEDURE; PEAK CK WAS <2 TIMES ABOVE UNL AND TROPONIN WAS 2 TIMES ABOVE UPPER NORMAL LEVEL (UNL). DURING THE ONE YEAR FOLLOW-UP, THE PATIENT REPORTED SILENT ISCHEMIA. A CORONARY ANGIOGRAM WAS PERFORMED. THERE WAS NO EVIDENCE OF MYOCARDIAL INFARCTION; HOWEVER, RE-PCI WAS PERFORMED TO AN UNKNOWN VESSEL. THE EVENT WAS REPORTED AS UNRELATED TO THE INDEX PROCEDURE AND CORDIS DEVICES.

    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 13186522

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R 6F GUIDING CATHETER| CYPHER SELECT STENT| 3.5X20MM BALLOON| 3.0X28MM BALLOON| CYPHER SELECT STENT| CYPHER SELECT STENT| 2.5X20MM BALLOON