BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 2033254 · Received March 30, 2011

    Report

    Report Number
    3003742446-2011-00140
    Event Type
    Injury
    Date Received
    March 30, 2011
    Date of Event
    November 1, 2007
    Report Date
    March 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

    COMPLAINT CONCLUSION: THIS PATIENT OF UNKNOWN AGE AND MEDICAL HISTORY EXPERIENCED A THROMBOTIC EVENT AND A MYOCARDIAL INFARCTION APPROXIMATELY ONE YEAR AFTER IMPLANTATION OF A CYPHER STENT. THE INDICATION OF THE INDEX PROCEDURE WAS UNKNOWN. PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED IN THE RIGHT CORONARY ARTERY (RCA) CORONARY ARTERY. 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. POST-INTERVENTIONAL TREATMENT WITH PLAVIX WAS REPORTED FOR AN UNKNOWN DURATION. APPROXIMATELY FOURTEEN MONTHS LATER, THE PATIENT EXPERIENCED THE THROMBOTIC EVENT AND MYOCARDIAL INFARCTION. IT WAS REPORTED THAT PLAVIX HAD BEEN DISCONTINUED AT SOME TIME PRIOR TO THE EVENTS. 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. THROMBOSIS AND MYOCARDIAL INFARCTION ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH STENT IMPLANTATION PROCEDURES. DISCONTINUATION OF ANTIPLATELET THERAPY MAY CAUSE THROMBUS FORMATION. THROMBUS FORMATION DECREASES THE AMOUNT OF BLOOD FLOW TO THE CARDIAC MUSCLE INDUCING AN MI. 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. HOWEVER, THERE ARE POSSIBLE PHARMACOLOGICAL FACTORS THAT MAY HAVE CONTRIBUTED TO THE EVENTS. NO CORRECTIVE OR PREVENTIVE ACTION WILL BE TAKEN AT THIS TIME BECAUSE THERE HAS BEEN NO SPECIFIC ROOT CAUSE IDENTIFIED THAT CAN BE ATTRIBUTED TO EITHER THE PRODUCT DESIGN, RAW MATERIALS USED OR THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    A PATIENT EXPERIENCED STENT THROMBOSIS AND SUBSEQUENT MYOCARDIAL INFARCTION APPROXIMATELY 14 MONTHS AFTER A CYPHER STENT WAS IMPLANTED IN HIS RIGHT CORONARY ARTERY (RCA). IT WAS REPORTED THAT PLAVIX HAD BEEN DISCONTINUED AT SOME TIME PRIOR TO THE EVENTS.

    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