BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1162743 · Received September 16, 2008

    Report

    Report Number
    9616099-2008-02253
    Event Type
    Injury
    Date Received
    September 16, 2008
    Date of Event
    August 7, 2008
    Report Date
    August 26, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT'S HISTORY IS SIGNIFICANT FOR HYPERLIPIDEMIA, HYPERTENSION, CURRENT SMOKER, AND FAMILY HISTORY OF CORONARY ARTERY DISEASE. THE PT WAS ON STATINS AND BETA-BLOCKERS. THE INDICATION FOR THE PROCEDURE WAS UNSTABLE ANGINA PECTORIS. THE VESSEL DIAMETER WAS 3MM AND THE LESION LENGTH WAS 6MM, THE LESION WAS DESCRIBED DE NOVO, NON-OSTIAL, BIFURCATION REQUIRING DOUBLE GUIDE WIRE, SMOOTH CONTOUR, READILY ACCESSIBLE, NO ANGULATIONS, CONCENTRIC, LITTLE OR NON CALCIFICATION, NO THROMBUS, TYPE B1, AND 55% STENOSED. THE PT RECEIVED CLOPIDOGREL 600 MG LOADING DOSE AND UNFRACTIONATED HEPARIN IN THE PROCEDURE ROOM. A 6 FRENCH GUIDING CATHETER WAS UTILIZED TO CANNULATE THE VESSEL, AND THE LESION WAS DIRECT STENTED WITH THE DEPLOYMENT OF A 3X30MM CYPHER SELECT PLUS STENT AT 18 ATMS. THE STENT WAS POST-DILATED FOR OPTIMAL EXPANSION WITH A 3X9MM BALLOON AT 9 ATMOSPHERES PERFORMED AT THE BIFURCATION. AFTER THE PROCEDURE, THE PT WAS PLACED ON ASPIRIN AND CLOPIDOGREL. THE PT WAS DISCHARGED HOME WITH CLOPIDOGREL FOR NINE MONTHS, STATINS, BETA-BLOCKERS AND ON PERMANENT ASPIRIN. THE PRODUCT REMAINS IMPLANTED AND THEREFORE IS NOT AVAILABLE FOR ANALYSIS. A REVIEW OF THE MFG DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MFG PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. REVIEW OF LOT REVEALED NO ANOMALIES DURING THE MFG AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. ADDITIONAL INFO WAS REQUESTED TO THE COATING SITE FOR CORONARY ARTERY RESTENOSIS. THE INVESTIGATION REVEALED THAT NO NON-CONFORMANCES WERE ISSUED DURING THE COATING PROCESS, AND THAT NO ANOMALIES WERE FOUND FOR THE LOT INVOLVED. RESTENOSIS IS A KNOWN POTENTIAL ADVERSE EVENT FOLLOWING STENT IMPLANTATION AND IS OFTEN ASSOCIATED WITH THE PROGRESSION OF CARDIOVASCULAR DISEASE. THE PT'S HISTORY OF FAMILY HISTORY, HYPERLIPIDEMIA, HYPERTENSION, SMOKING, AND BIFURCATION LESIONS PUTS HER AT AN INCREASED RISK FOR MACE. IT WAS ALSO REPORTED THAT THE RELATED BURST PRESSURE WAS EXCEEDED DURING IMPLANTATION OF THE CYPHER STENT. USAGE OTHER THAN THE APPROVED LABELING MAY INVOLVE RISKS NOT DESCRIBED IN THE LABELING. BASED ON THE PROVIDED INFO, THERE ARE PT FACTORS, VESSEL/LESION CHARACTERISTICS AND PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THE REPORTED PLAQUE AT THE PROXIMAL END OF THE CYPHER STENT IMPLANTED ELEVEN MONTHS PRIOR TO THE EVENT. THIS PRODUCT IS SIMILAR TO US CYPHER.

    Description of Event or Problem · 1

    A REPORT RECEIVED FROM THE STUDY INDICATED THAT THE PT COMPLAINED OF CHEST PAIN ELEVEN MONTHS AFTER THE INDEX PROCEDURE. AN ANGIOGRAM SHOWED A PLAGUE IN THE BEGINNING OF THE PREVIOUS IMPLANTED CYPHER SELECT PLUS STENT IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). THE EVENT WAS TREATED WITH A 3X8MM PROMUS STENT OVERLAPPING BY 2MM. THE EVENT WAS DETERMINED TO BE HIGHLY PROBABLE TO THE DEVICE AND PROCEDURE. THE EVENT RESOLVED WITHOUT SEQUEL.

    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 13245447

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| R