BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY XD

    MDR report key: 23807148 · Received December 15, 2025

    Report

    Report Number
    2124215-2025-90905
    Event Type
    Injury
    Date Received
    December 15, 2025
    Date of Event
    December 8, 2025
    Report Date
    January 27, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    UDI-DI
    08714729980568
    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 INFERIOR WALL MYOCARDIAL INFARCTION AND UNDERWENT PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY. THE TARGET LESION WAS LOCATED IN THE MID TO DISTAL RIGHT CORONARY ARTERY. A 4.00 X 38MM SYNERGY XD DRUG-ELUTING STENT (DES) WAS DEPLOYED. POST DEPLOYMENT, A TYPE B FLOW-LIMITING PROXIMAL STENT EDGE DISSECTION WAS OBSERVED, WITH TIMI II FLOW NOTED. THE PHYSICIAN FELT THAT LIPID RICH PLAQUE CONTRIBUTED TO THE DISSECTION. THE DISSECTION WAS COVERED WITH A 3.50 X 24MM SYNERGY XD DES, AND THE PROCEDURE WAS COMPLETED. THE PATIENT WAS STABLE POST-PROCEDURE AND FULLY RECOVERED. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS 90% STENOSED, MODERATELY TORTUOUS AND MODERATELY CALCIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A DISSECTION OCCURRED. THE PATIENT PRESENTED WITH INFERIOR WALL MYOCARDIAL INFARCTION AND UNDERWENT PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY. THE TARGET LESION WAS LOCATED IN THE MID TO DISTAL RIGHT CORONARY ARTERY. A 4.00 X 38MM SYNERGY XD DRUG-ELUTING STENT (DES) WAS DEPLOYED. POST DEPLOYMENT, A TYPE B FLOW-LIMITING PROXIMAL STENT EDGE DISSECTION WAS OBSERVED, WITH TIMI II FLOW NOTED. THE PHYSICIAN FELT THAT A LIPID RICH PLAQUE CONTRIBUTED TO THE DISSECTION. THE DISSECTION WAS COVERED WITH A 3.50 X 24MM SYNERGY XD DES, AND THE PROCEDURE WAS COMPLETED. THE PATIENT WAS STABLE POST-PROCEDURE AND FULLY RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    735771 SYNERGY XD CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC CORPORATION 0036114317 08714729980568

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Required Intervention