BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 3001135 · Received March 13, 2013

    Report

    Report Number
    9616099-2013-00075
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    December 28, 2012
    Report Date
    January 31, 2013
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    HARA, H ET AL (2012-12-28); INCIDENCE AND PREDICTORS FOR LATE TARGET LESION REVASCULARIZATION AFTER SIROLIMUS-ELUTING STENT IMPLANTATION; CIRCULATION JOURNAL 12-0570. PLEASE NOTE THAT THIS REPORT CONTAINS 23 INCIDENTS OF STENT FRACTURE EVENTS AND NO SPECIFIC INFORMATION REGARDING PATIENT DEMOGRAPHICS AND DEVICE SPECIFICS IS AVAILABLE TO DATE. COMPLAINT CONCLUSION: THE COMPLAINT RECEIVED FROM A LITERATURE REVIEW STATES THAT CYPHER STENTS BECAME FRACTURED AFTER IMPLANTATION. AS REPORTED IN THE LITERATURE ARTICLE, HARA ET AL INCIDENCE AND PREDICTORS FOR LATE TARGET LESION REVASCULARIZATION AFTER SIROLIMUS-ELUTING STENT IMPLANTATION; CIRCULATION JOURNAL 12-0570; REPORT THAT THERE WERE 23 INCIDENTS OF STENT FRACTURE REPORTED. THE CYPHER STENTS REMAIN IMPLANTED THUS UNAVAILABLE FOR ANALYSIS. THERE WAS NO STERILE LOT NUMBER INFORMATION AVAILABLE THUS NO DHR COULD BE PERFORMED. STENT FRACTURE IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH CYPHER STENT IMPLANTATION PROCEDURES AND IS LISTED IN THE IFU (INSTRUCTIONS FOR USE) AS SUCH. THERE ARE MULTIPLE FACTORS THAT CAN CONTRIBUTE TO STENT FRACTURE IN THE CORONARY ARTERIES. THE CORONARY ARTERIES ARE VERY DYNAMIC VESSELS THAT UNDERGO BIOMECHANICAL FORCES SUCH AS FLEXION, TORSION, COMPRESSION, AND ELONGATION. STUDIES HAVE ALSO REVEALED THAT STENT FRACTURES OCCUR IN CASES OF MULTIPLE STENTS AND OVERLAP RELATED TO AN ABNORMAL STRESS AREA THAT IS CREATED. 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.

    Description of Event or Problem · 1

    AS REPORTED IN THE LITERATURE ARTICLE, HARA ET AL INCIDENCE AND PREDICTORS FOR LATE TARGET LESION REVASCULARIZATION AFTER SIROLIMUS-ELUTING STENT IMPLANTATION; CIRCULATION JOURNAL 12-0570; REPORT THAT THERE WERE 23 STENT FRACTURE. NO ADDITIONAL INFORMATION IS OBTAINED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105480 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT (NIQ) NIQ CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R