BEUDAMED
    FDA Adverse Event Death Summary report: N

    KINETIX¿ PLUS

    MDR report key: 5077943 · Received September 15, 2015

    Report

    Report Number
    2134265-2015-06293
    Event Type
    Death
    Date Received
    September 15, 2015
    Date of Event
    August 17, 2015
    Report Date
    August 24, 2015
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQX
    PMA / PMN Number
    K081021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID: 2134265-2015-06294. IT WAS REPORTED THAT THE PATIENT DIED. AFTER A 185CM KINETIX® PLUS GUIDE WIRE CROSSED THE LESION, A 2.50X20MM PROMUS PREMIER® STENT WAS IMPLANTED TO THE LESION. A VESSEL PERFORATION WAS NOTED AFTER THE STENT WAS DEPLOYED. THE PHYSICIAN DEPLOYED ANOTHER STENT TO COVER THE PERFORATION. HOWEVER, LATER THAT NIGHT, THE PATIENT HAD A STROKE AND DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610691 KINETIX¿ PLUS WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - MAPLE GROVE H74939122032 0018005219

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death