BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1982292 · Received February 9, 2011

    Report

    Report Number
    3003742446-2011-00060
    Event Type
    Injury
    Date Received
    February 9, 2011
    Date of Event
    September 6, 2009
    Report Date
    January 14, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PATIENT OF UNKNOWN AGE AND MEDICAL HISTORY EXPERIENCED A THROMBOTIC EVENT AFTER IMPLANTATION OF A CYPHER STENT. THE PATIENT RECEIVED A CYPHER STENT IN THE RCA FOLLOWING CARDIAC CATHETERIZATION PERFORMED AS A RESULT OF CHEST PAIN. APPROXIMATELY THREE YEARS AND FIVE MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT SUFFERED A SUBSEQUENT THROMBOSIS AT THE SITE OF THE STENT CAUSING SERIOUS PERSONAL INJURY AND REQUIRING SUBSTANTIAL MEDICAL TREATMENT AND/OR THE REQUIREMENT OF LIFETIME PLAVIX THERAPY. 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 UNIDENTIFIED SECTION OF THE RCA. 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. 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 ARE A KNOWN POTENTIAL ADVERSE EVENT 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 THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT CARDIAC SURGERY ON (B)(6) 2006. DURING THIS OPERATION, A CYPHER STENT WAS IMPLANTED IN HIS CORONARY ARTERIES. THE STENT WAS PLACED IN PLAINTIFF'S RCA. THE PLAINTIFF RECEIVED A STENT FOLLOWING CARDIAC CATHETERIZATION PERFORMED AS A RESULT OF CHEST PAIN. AFTER IMPLANTATION OF THE STENT, PLAINTIFF SUFFERED A SUBSEQUENT THROMBOSIS AT THE SITE OF THE STENT ON OR ABOUT (B)(6) 2009, CAUSING SERIOUS PERSONAL INJURY AND REQUIRING SUBSTANTIAL MEDICAL TREATMENT AND/OR THE REQUIREMENT OF LIFETIME PLAVIX THERAPY.

    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 Life Threatening| R