BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1984112 · Received February 10, 2011

    Report

    Report Number
    3003742446-2011-00066
    Event Type
    Injury
    Date Received
    February 10, 2011
    Date of Event
    June 20, 2007
    Report Date
    January 18, 2011
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT REMAINED IMPLANTED IN THE PATIENT AND IS THUS NOT AVAILABLE FOR EVALUATION. THIS MALE PATIENT OF UNKNOWN AGE AND MEDICAL HISTORY EXPERIENCED A THROMBOTIC EVENT AND A MYOCARDIAL INFARCTION AFTER IMPLANTATION OF A CYPHER STENT. THE REPORT RECEIVED THROUGH THE LEGAL DEPARTMENT INDICATED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO AN ACUTE MYOCARDIAL INFARCTION (AMI) AND HAD A TOTAL OF FOUR CYPHER STENTS IMPLANTED FOR TREATMENT DURING THE INDEX PROCEDURE IN AN UNSPECIFIED VESSEL. DESCRIPTION OF THE VESSEL SUCH AS PERCENTAGE OF STENOSIS, TORTUOSITY, PRESENCE OF CALCIFICATION, ETC, WAS NOT REPORTED. VESSEL CLASSIFICATION WAS NOT REPORTED. BASELINE MEASUREMENT OF EJECTION FRACTION WAS NOT REPORTED. THERE IS NO INFORMATION REGARDING PROCEDURAL DETAILS SUCH AS: DEBULKING OR PRE-DILATION OF LESION BEFORE STENT DEPLOYMENT, PRE AND POST PROCEDURE CARDIAC ENZYME VALUES, PRE AND INTRA-PROCEDURE MEDICATIONS USED. ONE CYPHER STENT OF UNKNOWN LENGTH AND DIAMETER, UNKNOWN LOT NUMBER AND UNKNOWN EXPIRATION DATE, WAS DEPLOYED AT UNKNOWN PRESSURE IN AN UNKNOWN VESSEL. POST DILATION OF STENT WAS NOT REPORTED. THE RESIDUAL DIAMETER STENOSIS WAS NOT REPORTED. CONFIRMATION OF COMPLETE STENT APPOSITION TO THE VESSEL WALL BY IVUS WAS NOT REPORTED. TIMI FLOW WAS NOT REPORTED. THE REPORT DID NOT INDICATE WHEN THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. POST-INTERVENTIONAL TREATMENT WITH PLAVIX WAS REPORTED FOR AN UNKNOWN DURATION. APPROXIMATELY TEN MONTHS LATER, THE PATIENT EXPERIENCED LATE STENT THROMBOSIS AND MYOCARDIAL INFARCTION. NO ADDITIONAL INFORMATION WAS AVAILABLE. THE PRODUCT REMAINED IMPLANTED IN THE PATIENT AND IS THUS NOT AVAILABLE FOR EVALUATION. A DEVICE HISTORY RECORDS (DHR) REVIEW COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER OF THE PRODUCT WAS NOT REPORTED. THROMBOTIC EVENTS AND MYOCARDIAL INFARCTIONS ARE KNOWN POTENTIAL ADVERSE EVENTS FOLLOWING STENT IMPLANTATION. PATIENTS WHO ARE KNOWN TO BE AT HIGH-RISK FOR THROMBOTIC EVENTS INCLUDE THOSE WITH LONG LESIONS, A VESSEL DIAMETER LESS THAN 3MM AND PREVIOUS THROMBUS. WITH SUCH LIMITED PATIENT AND PROCEDURAL INFORMATION AVAILABLE FOR REVIEW, THE LACK OF AVAILABILITY OF THE PRODUCT'S LOT NUMBER TO PERFORM A DHR REVIEW AND THE UNAVAILABILITY OF THE PRODUCT TO ANALYZE, IT IS NOT POSSIBLE TO DETERMINE WHAT FACTORS MAY HAVE CONTRIBUTED TO THESE EVENTS AND NO CORRECTIVE OR PREVENTIVE ACTION WILL BE TAKEN AT THIS TIME. THIS IS ONE OF FOUR PRODUCTS USED DURING THE SAME PROCEDURE. PLEASE REFERENCE MFR REPORT # 3003742446-2011-00063, # 3003742446-2011-00064, #3003742446-2011-00065, AND # 3003742446-2011-00066. PLEASE NOTE THAT THIS IS THE INITIAL/FINAL REPORT FOR THIS PRODUCT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED THROUGH THE LEGAL DEPARTMENT INDICATED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO AN ACUTE MYOCARDIAL INFARCTION (AMI) AND HAD A TOTAL OF FOUR CYPHER STENTS IMPLANTED FOR TREATMENT DURING THE INDEX PROCEDURE. APPROXIMATELY TEN MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT EXPERIENCED AN AMI AND LATE STENT THROMBOSIS. NO TARGET LESION INFORMATION WAS PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT (NIQ) NIQ CORDIS LLC (PR) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R