BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 17380041 · Received July 24, 2023

    Report

    Report Number
    2124215-2023-39040
    Event Type
    Injury
    Date Received
    July 24, 2023
    Date of Event
    July 4, 2023
    Report Date
    July 24, 2023
    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 HIGHLY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY. A 3.50 X 16 SYNERGY WAS DEPLOYED AND A FLOW LIMITING EDGE DISSECTION WAS NOTED. AN ADDITIONAL DRUG ELUTING STENT WAS IMPLANTED TO RESTORE FLOW AND THE PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1369375 SYNERGY CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC CORPORATION 10618 0027751473

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Required Intervention