BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS PREMIER SELECT

    MDR report key: 14048318 · Received April 7, 2022

    Report

    Report Number
    2134265-2022-04110
    Event Type
    Injury
    Date Received
    April 7, 2022
    Date of Event
    March 19, 2022
    Report Date
    April 7, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A DISSECTION OCCURRED. THE PATIENT WAS DIAGNOSED WITH SMALL VESSEL DISEASE (SDV) OF THE LEFT ANTERIOR DESCENDING ARTERY (LAD) AND WAS REFERRED FOR A SINGLE VESSEL PLASTY. THE 80% TARGET LESION, WITH A MILD ANGULATION, WAS LOCATED IN A MODERATELY CALCIFIED, MILDLY TORTUOUS LAD, AND WAS PREDILATED WITH A SEMI COMPLIANT (SC) BALLOON. FOLLOWING PREDILATATION, A 38 X 2.50 PROMUS PREMIER SELECT STENT WAS DEPLOYED IN THE LAD. SOON AFTER DEPLOYMENT, A DISTAL STENT EDGE DISSECTION WAS NOTED. A 16 X 2.50 PROMUS PREMIER SELECT WAS DEPLOYED TO COVER THE DISSECTION AND COMPLETE THE PROCEDURE. NO OTHER DEVICES WERE USED TO HELP DELIVER THE STENT AT THE LESION SITE, AND THERE WERE NO ISSUES WITH STENT DEPLOYMENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1823807 PROMUS PREMIER SELECT STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC CORPORATION 10668 0028407088

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Required Intervention