BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 19670799 · Received July 3, 2024

    Report

    Report Number
    2124215-2024-41239
    Event Type
    Injury
    Date Received
    July 3, 2024
    Date of Event
    June 3, 2024
    Report Date
    July 3, 2024
    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 TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 2.75 X 38 MM SYNERGY WAS DEPLOYED AND POST-DILATED AND A PROXIMAL EDGE, FLOW LIMITING DISSECTION WAS NOTED. TO COVER THE DISSECTION, A 3.50 X 24 MM SYNERGY WAS DEPLOYED PROXIMALLY AND THE PROCEDURE WAS COMPLETED. THE PATIENT FULLY RECOVERED AND WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    901588 SYNERGY CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC CORPORATION 10623 0030962550

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention