BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY XD

    MDR report key: 23888969 · Received December 24, 2025

    Report

    Report Number
    2124215-2025-92966
    Event Type
    Injury
    Date Received
    December 24, 2025
    Date of Event
    December 15, 2025
    Report Date
    December 24, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    UDI-DI
    08714729980391
    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 VESSEL DISSECTION OCCURRED. THE TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY. A 3.00 X 48MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR DILATION. HOWEVER, UPON DEPLOYMENT OF THE STENT, A FLOW LIMITING DISSECTION WAS OBSERVED AT THE DISTAL STENT EDGE, AND IT WAS COVERED WITH ANOTHER 2.75 X 12MM SYNERGY XD STENT TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS. PATIENT WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1801573 SYNERGY XD CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC CORPORATION 0036534523 08714729980391

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female Required Intervention