BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 3172050 · Received June 17, 2013

    Report

    Report Number
    3003742446-2013-00075
    Event Type
    Injury
    Date Received
    June 17, 2013
    Date of Event
    January 1, 2012
    Report Date
    May 22, 2013
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT EXACT EVENT DATE AND STENT IMPLANTATION DATE ARE UNKNOWN; HOWEVER, IT WAS REPORTED THAT THE STENT WAS PLACED IN 2007 AND THE EVENT OCCURED IN 2012. AS REPORTED FROM THE MEDICAL AFFAIRS, THE PATIENT HAD A CYPHER STENT PLACED IN AN UNSPECIFIED VESSEL FOR AN UNSPECIFIED REASON. APPROXIMATELY 5 YEARS LATER, THE PATIENT HAD TWO UNSPECIFIED STENTS PLACED IN UNKNOWN VESSELS FOR UNSPECIFIED REASONS. NO FURTHER INFORMATION WAS GIVEN. THE STUDY STENT REMAIN IMPLANTED THUS UNAVAILABLE FOR ANALYSIS. THERE IS NO LOT NUMBER INFORMATION AVAILABLE THUS NO DHR COULD BE PERFORMED. IN-STENT RESTENOSIS IS A WELL-KNOWN POTENTIAL COMPLICATION FOR THIS TYPE OF PROCEDURE AND IS LISTED IN THE IFU. IN THE LITERATURE, IN-STENT STENOSIS RATES RANGE FROM 11% TO 39% FROM 6 TO 12 MONTHS AFTER STENT PLACEMENT. RATES WERE HIGHER IN OLDER PATIENTS WITH MORE SEVERE ATHEROSCLEROSIS AND DEPENDED ON THE TYPE OF STENOSIS TREATED. IN-STENT STENOSIS WAS MORE PREVALENT IN OSTIAL STENT PLACEMENT PROCEDURES. STENOSES IN STENTS ARE USUALLY TREATED WITH INTRASTENT PTA OR PLACEMENT OF A SECOND STENT. PROGRESSION OF ATHEROSCLEROTIC DISEASE IS KNOWN TO CAUSE INSTENT RESTENOSIS AND DOES NOT INDICATE A DEVICE FAILURE. INTRA-ARTERIAL STENT PLACEMENT IS A TREATMENT OF THE DISEASE PROCESS AND IT NOT A PREVENTIVE OR CURE FOR THE PROGRESSION OF SYMPTOMS OF ATHEROSCLEROTIC ARTERY DISEASE. ALL PRODUCTS UNDERGO A 100% INSPECTION PRIOR TO RELEASE FOR MARKETING. THERE IS NO EVIDENCE OF MANUFACTURING ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. DUE TO LACK OF INFORMATION, NO CONCLUSION CAN BE DETERMINED.

    Description of Event or Problem · 1

    AS REPORTED FROM THE MEDICAL AFFAIRS, THE PATIENT HAD A CYPHER STENT PLACED IN AN UNSPECIFIED VESSEL FOR AN UNSPECIFIED REASON. APPROXIMATELY 5 YEARS LATER, THE PATIENT HAD TWO UNSPECIFIED STENTS PLACED IN UNKNOWN VESSELS FOR UNSPECIFIED REASONS. NO FURTHER INFORMATION WAS GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274460 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT (NIQ) NIQ CORDIS LLC (PR) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention