BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    MDR report key: 2840654 · Received November 20, 2012

    Report

    Report Number
    2134265-2012-07152
    Event Type
    Injury
    Date Received
    November 20, 2012
    Report Date
    October 26, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT FOLLOWING A STENTING TREATMENT PROCEDURE, CHEST PAIN OCCURRED AND FOREIGN MATERIAL WAS FOUND IN A PATIENT'S VESSEL. THE PROMUS ELEMENT PLUS STENT WAS IMPLANTED TO TREAT AN UNSPECIFIED TARGET LESION. FOLLOWING STENT IMPLANTATION, THE PATIENT CONTINUED TO EXPERIENCE CHEST PAIN. A SCAN IDENTIFIED FOREIGN MATERIAL IN THE PATIENT'S VESSEL. ADDITIONAL SURGERY WAS REQUIRED TO REMOVE THE MATERIAL, WHICH WAS IDENTIFIED AS A PIECE OF PLASTIC. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - MAPLE GROVE UNK717

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention