BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    MDR report key: 7425522 · Received April 12, 2018

    Report

    Report Number
    2134265-2018-03002
    Event Type
    Malfunction
    Date Received
    April 12, 2018
    Report Date
    March 14, 2018
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: URAM JIN, MD, ET AL, LONGITUDINAL STENT-STRUT INJURY AT THE DISTAL END OF A NEWER-GENERATION DRUG-ELUTING STENT, KOREAN CIRC J. 2018 FEB;48(2):176-178, HTTPS://DOI.ORG/10.4070/KCJ.2017.0180, PISSN 1738-5520·EISSN 1738-5555. DEVICE IS COMBINATION PRODUCT. (B)(4). DEVICE EVALUATED BY MFR: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE INVESTIGATION CONCLUSION IS DEVICE NOT RETURNED AS THE COMPLAINT DID NOT INCLUDE RETURNED DEVICE REVIEW AND LACKED THE OBJECTIVE EVIDENCE OR DESCRIPTIVE CONDITIONS OF THE EVENT REQUIRED TO DETERMINE WHAT COULD HAVE CONTRIBUTED TO THE EVENT. (B)(4).

    Description of Event or Problem · 1

    SAME ARTICLE AS MDR#: 2134265-2018-03001. IT WAS VIA JOURNAL ARTICLE THAT STENT DAMAGE OCCURRED. TO ADDRESS INCREASING CONCERNS REGARDING LONGITUDINAL STENT DEFORMATION (LSD) WITH NEWER-GENERATION DRUG-ELUTING STENTS (DESS), THE PROMUS PREMIER¿ WAS REDESIGNED TO REINFORCE THE AXIAL STRENGTH OF PROXIMAL END, WHERE ALMOST ALL LSDS OCCURRED IN THE PREVIOUS PROMUS ELEMENT¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268553 PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY UNK634

    Patients

    Seq Age Sex Outcome Treatment
    1