BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN CYPHER JAPAN

    MDR report key: 8042026 · Received November 6, 2018

    Report

    Report Number
    9616099-2018-02495
    Event Type
    Malfunction
    Date Received
    November 6, 2018
    Date of Event
    September 14, 2018
    Report Date
    November 6, 2018
    Manufacturer
    CORDIS CASHEL
    Product Code
    NIQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS ARTICLE WAS FOUND DURING A RECENT LITERATURE SEARCH OF THIS DEVICE. PLEASE NOTE THAT PATIENT SPECIFIC DETAILS (DEMOGRAPHICS, MEDICAL HISTORY AND REASON FOR INTERVENTION) ARE NOT AVAILABLE. THE DEVICE IS A CYPHER STENT AND THE CATALOG AND LOT NUMBERS ARE NOT AVAILABLE. USUI E, YONETSU T, KANAJI Y, HOSHINO M, YAMAGUCHI M, HADA M, HAMAYA R, KANNO Y, MURAI T, LEE T, HIRAO K, KAKUTA T. PREVALENCE OF NEOATHEROSCLEROSIS IN SIROLIMUS-ELUTING STENTS IN A VERY LATE PHASE AFTER IMPLANTATION. EUROINTERVENTION 2018; JAA-443 2018, DOI: 10.4244/EIJ-D-18-00486. AS REPORTED IN THE PUBLICATION BY USUI, E. ET AL., (2018). PREVALENCE OF NEOATHEROSCLEROSIS IN SIROLIMUS-ELUTING STENTS IN A VERY LATE PHASE AFTER IMPLANTATION. EUROINTERVENTION 2018; JAA-443; THERE WERE FIVE CASES OF STENT MALAPPOSITION POST CYPHER STENT IMPLANTATION AT THE GREATER THAN 10 YEAR FOLLOW-UP. THE PRODUCTS WERE NOT RETURNED FOR ANALYSIS. NO LOT NUMBERS WERE PROVIDED THEREFORE PRODUCT HISTORY RECORD (PHR) REVIEWS COULD NOT BE GENERATED. THE REPORTED ¿STENT UNDEREXPANDED¿ COULD NOT BE CONFIRMED AS THE DEVICES WERE NOT RETURNED FOR ANALYSIS. THE EXACT CAUSE COULD NOT BE DETERMINED. VESSEL CHARACTERISTICS, ALTHOUGH UNKNOWN, MAY HAVE CONTRIBUTED TO THE REPORTED EVENT, AS CALCIFIED LESIONS MAY BE RESISTANT TO STENTING. ACCORDING TO THE SAFETY INFORMATION IN THE INSTRUCTIONS FOR USE, ¿CONTRAINDICATIONS CORONARY ARTERY STENTING IS GENERALLY CONTRAINDICATED IN THE FOLLOWING PATIENT TYPES: PATIENTS JUDGED TO HAVE A LESION THAT PREVENTS COMPLETE INFLATION OF AN ANGIOPLASTY BALLOON.¿ ACCORDING TO THE DIRECTIONS FOR USE, WHICH IS NOT INTENDED AS A MITIGATION OF RISK, ¿UNDER FLUOROSCOPIC VISUALIZATION, INFLATE THE BALLOON TO DEPLOY THE STENT BUT DO NOT EXCEED THE LABELED RATED BURST PRESSURE (16 ATMOSPHERES). OPTIMAL EXPANSION REQUIRES THE STENT TO BE IN FULL CONTACT WITH THE ARTERY WALL, WITH THE STENT INTERNAL DIAMETER MATCHING THE SIZE OF THE REFERENCE VESSEL DIAMETER. STENT WALL CONTACT SHOULD BE VERIFIED THROUGH ROUTINE ANGIOGRAPHY OR INTRAVASCULAR ULTRASOUND.¿ NEITHER THE PHR NOR THE VERY LIMITED INFORMATION AVAILABLE SUGGESTS A DESIGN OR MANUFACTURING RELATED CAUSE FOR THE REPORTED EVENT; THEREFORE, NO CORRECTIVE/PREVENTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    AS REPORTED IN THE PUBLICATION BY USUI, E. ET AL., (2018). PREVALENCE OF NEOATHEROSCLEROSIS IN SIROLIMUS-ELUTING STENTS IN A VERY LATE PHASE AFTER IMPLANTATION. EUROINTERVENTION 2018; JAA-443; THERE WERE FIVE CASES OF STENT MALAPPOSITION POST CYPHER STENT IMPLANTATION AT THE GREATER THAN 10 YEAR FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    882275 UNKNOWN CYPHER JAPAN CORONARY DRUG-ELUTING STENT NIQ CORDIS CASHEL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1