BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY MEGATRON

    MDR report key: 23248252 · Received October 8, 2025

    Report

    Report Number
    2124215-2025-65852
    Event Type
    Injury
    Date Received
    October 8, 2025
    Date of Event
    September 12, 2025
    Report Date
    October 30, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    UDI-DI
    08714729985419
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    GOOD FAITH EFFORT ATTEMPTS WERE MADE TO TRY AND RETRIEVE ADDITIONAL DETAILS REGARDING THE REPORTED EVENT, BUT FURTHER INFORMATION WAS UNABLE TO BE OBTAINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A DISSECTION OCCURRED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE AND UNDERWENT PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 3.50 X 24MM SYNERGY MEGATRON DRUG-ELUTING STENT WAS SUCCESSFULLY DEPLOYED. POST DEPLOYMENT, A NON-FLOW LIMITING DISTAL EDGE DISSECTION WAS OBSERVED. ANOTHER STENT WAS IMPLANTED TO COVER THE DISSECTION, AND THE PROCEDURE WAS COMPLETED. THE PATIENT WAS STABLE POST PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A DISSECTION OCCURRED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE AND UNDERWENT PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 3.50 X 24MM SYNERGY MEGATRON DRUG-ELUTING STENT WAS SUCCESSFULLY DEPLOYED. POST DEPLOYMENT, A NON-FLOW LIMITING DISTAL EDGE DISSECTION WAS OBSERVED. ANOTHER STENT WAS IMPLANTED TO COVER THE DISSECTION, AND THE PROCEDURE WAS COMPLETED. THE PATIENT WAS STABLE POST PROCEDURE. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS 90% STENOSED, MILDLY TORTUOUS, AND MILDLY CALCIFIED. THE LESION WAS PRE-DILATED WITH A SEMI-COMPLIANT BALLOON, AND THE STENT WAS FULLY DEPLOYED AT 11 ATMOSPHERES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2611294 SYNERGY MEGATRON CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC CORPORATION 0035559861 08714729985419

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention