BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY MEGATRON

    MDR report key: 21403838 · Received February 18, 2025

    Report

    Report Number
    2124215-2025-09512
    Event Type
    Injury
    Date Received
    February 18, 2025
    Date of Event
    February 14, 2025
    Report Date
    March 17, 2025
    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 MAIN CORONARY ARTERY, EXTENDING INTO THE MIDDLE LEFT ANTERIOR DESCENDING ARTERY. A 3.50 X 24MM SYNERGY MEGATRON STENT WAS ADVANCED AND DEPLOYED. HOWEVER, POST-DEPLOYMENT, A FLOW-LIMITING, TYPE B DISSECTION AT THE DISTAL EDGE OF THE STENT WAS OBSERVED. THE PATIENT EXPERIENCED SLOW FLOW AND CHANGES IN ELECTROCARDIOGRAM (ECG). A 3.50 X 12 MM DRUG-ELUTING STENT (DES) WAS DEPLOYED TO COVER THE DISSECTION. NO FURTHER COMPLICATIONS WERE REPORTED AND THE PATIENT REMAINED STABLE AND FULLY RECOVERED. IT WAS FURTHER REPORTED THAT THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND NON-CALCIFIED SEGMENT OF THE MIDDLE LEFT ANTERIOR DESCENDING ARTERY. A 3.25 X 10 MM NON-COMPLIANT BALLOON WAS USED TO PRE-DILATE THE LESION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A DISSECTION OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT MAIN CORONARY ARTERY, EXTENDING INTO THE MIDDLE LEFT ANTERIOR DESCENDING ARTERY. A 3.50 X 24MM SYNERGY MEGATRON STENT WAS ADVANCED AND DEPLOYED. HOWEVER, POST-DEPLOYMENT, A FLOW-LIMITING, TYPE B DISSECTION AT THE DISTAL EDGE OF THE STENT WAS OBSERVED. THE PATIENT EXPERIENCED SLOW FLOW AND CHANGES IN ELECTROCARDIOGRAM (ECG). A 3.50 X 12 MM DRUG-ELUTING STENT (DES) WAS DEPLOYED TO COVER THE DISSECTION. NO FURTHER COMPLICATIONS WERE REPORTED AND THE PATIENT REMAINED STABLE AND FULLY RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2571880 SYNERGY MEGATRON CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC CORPORATION 0032936600

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention