BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS PREMIER SELECT

    MDR report key: 9695369 · Received February 11, 2020

    Report

    Report Number
    2134265-2020-00813
    Event Type
    Injury
    Date Received
    February 11, 2020
    Date of Event
    January 13, 2020
    Report Date
    February 11, 2020
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DISSECTION OCCURRED. A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY WAS PERFORMED ON DE NOVO TARGET LESION LOCATED IN THE LEFT CIRCUMFLEX (LCX). A 32 X 3.00 PROMUS PREMIER SELECT STENT WAS DEPLOYED IN THE LCX. AN ORTHOGONAL VIEW WAS TAKEN TO VIEW THE DEPLOYED STENT AND NOTED AN EDGE DISSECTION. TO COVER THE EDGE DISSECTION, ANOTHER STENT WAS DEPLOYED. THE PROCEDURE WAS COMPLETED AND THE PATIENT WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156335 PROMUS PREMIER SELECT STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC CORPORATION 10667 0024217450

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention