BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 18908702 · Received March 14, 2024

    Report

    Report Number
    2124215-2024-15678
    Event Type
    Injury
    Date Received
    March 14, 2024
    Date of Event
    March 6, 2024
    Report Date
    March 14, 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

    Additional Manufacturer Narrative · 0

    E1 INITIAL REPORTER ADDRESS: (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A DISSECTION OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 2.75 X 24 MM SYNERGY WAS DEPLOYED AND POST-DILATED AND A PROXIMAL EDGE, FLOW LIMITING DISSECTION WAS NOTICED. TO COVER THE DISSECTION, A NON-BOSTON SCIENTIFIC STENT WAS DEPLOYED PROXIMALLY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT FULLY RECOVERED AND WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1017791 SYNERGY CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC CORPORATION 10620 0030661594

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention