BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 5077578 · Received September 15, 2015

    Report

    Report Number
    3003742446-2015-00057
    Event Type
    Injury
    Date Received
    September 15, 2015
    Report Date
    August 20, 2015
    Manufacturer
    CORDIS CORPORATION
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: AS REPORTED BY MEDICAL AFFAIRS, AN MRI TECHNICIAN CALLED IN REQUESTING MEDICAL INFORMATION AND ADDITIONALLY REPORTED ADVERSE EVENTS. ON U/U/U, THE PATIENT HAD 2 CYPHER STENTS PLACED IN RCA FOR "OCCLUSION". ON U/U/U PATIENT HAD 4 CYPHER STENTS PLACED IN UNKNOWN VESSEL FOR "OCCLUSION". IT WAS REPORTED THAT ALL STENTS MAY HAVE BEEN PLACED IN (B)(6) 2007 ON 2 SEPARATE DATES WHICH COULD NOT BE CLARIFIED FURTHER. IT COULD NOT BE CLARIFIED WHICH SET OF STENTS WERE IMPLANTED FIRST. THE MRI TECHNICIAN REPORTED THAT SHE HAD NO TIME TO TALK SO NO FURTHER INFORMATION WAS OBTAINED AT THE TIME OF THE CALL. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED WITHOUT A LOT NUMBER. WITHOUT FURTHER TESTING, IT IS NOT POSSIBLE TO DETERMINE THE SOURCE OF THIS EVENT. PATIENT, PROCEDURAL AND PHARMACOLOGIC FACTORS MAYBE HAVE CONTRIBUTED TO THE REPORTED EVENT. RESTENOSIS IS ASSOCIATED WITH THE PROGRESSION OF CARDIOVASCULAR DISEASE AND IS A KNOWN POTENTIAL ADVERSE EVENT FOLLOWING STENT IMPLANTATION. WELL DOCUMENTED POTENTIAL COMPLICATION OF STENT PLACEMENT IS SUBSEQUENT INTIMAL HYPERPLASIA AND OCCLUSION. PROGRESSION OF ATHEROSCLEROSIS IS AN EXPECTED OUTCOME OF THE DISEASE PROCESS. THERE IS NO INDICATION THAT THE EVENT WAS RELATED TO A DESIGN OR MANUFACTURING ISSUE, THEREFORE NO CORRECTIVE ACTION IS NEEDED.

    Description of Event or Problem · 1

    AS REPORTED BY MEDICAL AFFAIRS, AN MRI TECHNICIAN CALLED IN REQUESTING MEDICAL INFORMATION AND ADDITIONALLY REPORTED ADVERSE EVENTS. ON U/U/U, THE PATIENT HAD 2 CYPHER STENTS PLACED IN RCA FOR "OCCLUSION". ON U/U/U PATIENT HAD 4 CYPHER STENTS PLACED IN UNKNOWN VESSEL FOR "OCCLUSION". IT WAS REPORTED THAT ALL STENTS MAY HAVE BEEN PLACED IN (B)(6) 2007 ON 2 SEPARATE DATES WHICH COULD NOT BE CLARIFIED FURTHER. IT COULD NOT BE CLARIFIED WHICH SET OF STENTS WERE IMPLANTED FIRST. THE MRI TECHNICIAN REPORTED THAT SHE HAD NO TIME TO TALK SO NO FURTHER INFORMATION WAS OBTAINED AT THE TIME OF THE CALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608354 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT (NIQ) NIQ CORDIS CORPORATION NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention