BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 2050858 · Received April 12, 2011

    Report

    Report Number
    3003742446-2011-00175
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    November 25, 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

    THE STENT REMAINS IMPLANTED AND THUS IS UNAVAILABLE FOR ANALYSIS. THERE IS NO STERILE LOT NUMBER INFORMATION AVAILABLE THUS NO DHR COULD BE PERFORMED. VERY LATE THROMBOSIS IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH STENT IMPLANTATION PROCEDURES AND IS LISTED IN THE IFU AS SUCH. THE ACT OF STENT IMPLANTATION PRODUCES INTENDED DAMAGE TO THE INTIMA OF THE VESSEL WALL IN ORDER TO REMODEL THE WALL AND REESTABLISH PATENCY OF THE VESSEL. THE DISRUPTION OF THE INTIMAL LAYERS TRIGGERS THE IMMUNE SYSTEM TO HEAL THE DAMAGED AREAS, THUS ACTIVATING THE CLOTTING MECHANISM AS WELL AS THE INFLAMMATORY RESPONSE. THE COMBINATION OF INFLAMMATORY RESPONSE AND CLOTTING CASCADE CAN LEAD TO THROMBUS FORMATION IN SIDE OF THE STENT AROUND THE DAMAGED AREAS. IT IS UNKNOWN IF THE PATIENT WAS MAINTAINED ON AN ANTIPLATELET MEDICATION REGIMEN. THERE IS NO EVIDENCE OF MANUFACTURING ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. REVIEW OF THE LIMITED INFORMATION DOES NOT SUGGEST WHAT FACTORS MAY HAVE CONTRIBUTED TO THIS EVENT OF VERY LATE THROMBOSIS.

    Description of Event or Problem · 1

    THE COMPLAINT RECEIVED STATES THAT APPROXIMATELY TWO YEARS POST IMPLANTATION OF CYPHER STENT, THIS PATIENT SUFFERED VERY LATE IN-STENT THROMBOSIS. THIS MALE PATIENT HAD TWO CYPHER STENTS IMPLANTED: THE FIRST CYPHER WAS IMPLANTED AT THE LEFT ANTERIOR DESCENDING ARTERY AND THE SECOND CYPHER WAS IMPLANTED AT THE MID-RIGHT CORONARY ARTERY. TWO YEARS AFTER INDEX PROCEDURE, THE PATIENT SUFFERED LATE THROMBOSIS AT THE LEFT ANTERIOR DESCENDING ARTERY.

    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