BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 4575515 · Received March 6, 2015

    Report

    Report Number
    1016427-2015-00016
    Event Type
    Injury
    Date Received
    March 6, 2015
    Date of Event
    January 6, 2015
    Report Date
    February 11, 2015
    Manufacturer
    CORDIS CORPORATION
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: LEI, GAO AND ET AL (2015). OPTICAL COHERENCE TOMOGRAPHIC EVALUATION OF THE EFFECT OF CIGARETTE SMOKING ON VASCULAR HEALING AFTER SIROLIMUS-ELUTING STENT IMPLANTATION. THE AMERICAN JOURNAL OF CARDIOLOGY, 1-7. THE MDR REPORT IS BEING SUBMITTED FOR MULTIPLE PATIENTS WITH NO PATIENT DEMOGRAPHICS OR DEVICE SPECIFICS. THE PUBLICATION HAS BEEN ATTACHED TO THE MDR REPORT. COMPLAINT CONCLUSION: AS NOTED IN THE PUBLICATION BY GAO ET AL OPTICAL COHERENCE TOMOGRAPHIC EVALUATION OF THE EFFECT OF CIGARETTE SMOKING ON VASCULAR HEALING AFTER SIROLIMUS-ELUTING STENT IMPLANTATION, THE AMERICAN JOURNAL OF CARDIOLOGY (2015) 1-7; QUANTITATIVE CORONARY ANGIOGRAPHY (QCA) AT FOLLOW-UP REVEALED 15 CASES OF IN-STENT RESTENOSIS (3 CURRENT SMOKERS, 4 FORMER SMOKERS, AND 8 NEVER SMOKERS). OPTICAL COHERENCE TOMOGRAPHY FINDINGS REVEALED 9 CASES OF THROMBUS (3 CURRENT SMOKERS, 3 FORMER SMOKERS, 3 NEVER SMOKERS). THE STENTS ARE UNAVAILABLE FOR ANALYSIS. THERE ARE NO STERILE LOT NUMBERS AVAILABLE, THEREFORE A REVIEW OF THE MANUFACTURING DOCUMENTATION COULD NOT BE PERFORMED. RESTENOSIS IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH IMPLANTING CORONARY ARTERY STENTS AND IS OFTEN ASSOCIATED WITH THE PROGRESSION OF CORONARY ARTERY DISEASE. BASED ON THE AVAILABLE INFORMATION THERE IS NO EVIDENCE TO SUGGEST THAT THE EVENT WAS DESIGN OR MANUFACTURING RELATED THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN. 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 AND INSTIGATE VESSEL REMODELING AROUND THE STENT, PRODUCING GAPS BETWEEN THE STENT AND THE VESSEL WALL. 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 NOTED IN THE PUBLICATION BY GAO ET AL OPTICAL COHERENCE TOMOGRAPHIC EVALUATION OF THE EFFECT OF CIGARETTE SMOKING ON VASCULAR HEALING AFTER SIROLIMUS-ELUTING STENT IMPLANTATION, THE AMERICAN JOURNAL OF CARDIOLOGY (2015) 1-7; QUANTITATIVE CORONARY ANGIOGRAPHY (QCA) AT FOLLOW-UP REVEALED 15 CASES OF IN-STENT RESTENOSIS (3 CURRENT SMOKERS, 4 FORMER SMOKERS, AND 8 NEVER SMOKERS). OPTICAL COHERENCE TOMOGRAPHY FINDINGS REVEALED 9 CASES OF THROMBUS (3 CURRENT SMOKERS, 3 FORMER SMOKERS, 3 NEVER SMOKERS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157279 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT (NIQ) NIQ CORDIS CORPORATION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening