BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS PREMIER?

    MDR report key: 3882026 · Received June 18, 2014

    Report

    Report Number
    2134265-2014-03579
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    May 16, 2014
    Report Date
    May 23, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. (B)(4). DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT DISLODGEMENT AND MIGRATION OCCURRED. A PROMUS PREMIER STENT WAS IMPLANTED IN AN UNSPECIFIED VESSEL. A SECOND PROMUS PREMIER STENT WAS THEN ADVANCED BUT GOT STUCK WITHIN THE FIRST STENT. ON ATTEMPTING TO DISENGAGE THE SECOND STENT, THE STENT CAME OFF THE BALLOON AND "FLOATED" IN THE LEFT MAIN STEM (LMS). THE DISLODGED STENT WAS THEN CRUSHED WITH A THIRD PROMUS PREMIER STENT IN THE LMS. THE PROCEDURE WAS COMPLETED AND THE PATIENT WAS FEELING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359263 PROMUS PREMIER? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY UNK758

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention