BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 15983202 · Received December 14, 2022

    Report

    Report Number
    2124215-2022-52364
    Event Type
    Injury
    Date Received
    December 14, 2022
    Date of Event
    November 27, 2022
    Report Date
    December 14, 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 TARGET LESION WAS LOCATED IN THE MID RIGHT CORONARY ARTERY. A 2.75 X 24 SYNERGY WAS DEPLOYED. POST DEPLOYMENT, A NON-FLOW LIMITING DISSECTION WAS NOTED AT THE PROXIMAL EDGE OF THE STENT. THE DISSECTION WAS COVERED WITH A 3.00 X 16 SYNERGY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2152981 SYNERGY CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC CORPORATION 10620 0028295118

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention