BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    MDR report key: 6831542 · Received August 30, 2017

    Report

    Report Number
    2134265-2017-08681
    Event Type
    Malfunction
    Date Received
    August 30, 2017
    Report Date
    August 14, 2017
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: YAMADA, R., OKURA, H., KUME, T., FUKUHARA, K., KOYAMA, T., HIGA, T., NEISHI, Y., YOSHIDA, K., UEMURA, S. (2017). IMPACT OF STENT PLATFORM ON LONGITUDINAL STENT DEFORMATION: AN IN VIVO FREQUENCY DOMAIN OPTICAL COHERENCE TOMOGRAPHY STUDY. CARDIOVASC INTERV THER, 32(3):199-205. DOI: 10.1007/S12928-016-0403-3. (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE ROOT CAUSE IS NOT CONFIRMED. IF THERE IS ANY FURTHER RELEVANT INFORMATION, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE THAT LONGITUDINAL STENT DEFORMATION OCCURRED FOLLOWING IMPLANT OF PROMUS ELEMENT DRUG-ELUTING STENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611634 PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY UNK634

    Patients

    Seq Age Sex Outcome Treatment
    1