BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY XD

    MDR report key: 20632474 · Received November 7, 2024

    Report

    Report Number
    2124215-2024-70135
    Event Type
    Injury
    Date Received
    November 7, 2024
    Date of Event
    September 23, 2024
    Report Date
    December 26, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: DATE OF EVENT: CORRECTED.

    Description of Event or Problem · 0

    AGENT: (B)(6). IT WAS REPORTED THAT RESTENOSIS OCCURRED. ON (B)(6) 2022, THE SUBJECT PRESENTED WITH UNSTABLE ANGINA AND THE MID RCA WAS TREATED WITH 4.0 MM X 12 MM SYNERGY DRUG ELUTING STENT. ON (B)(6) 2024, THE SUBJECT WAS DIAGNOSED WITH IN STENT RESTENOSIS (ISR) AND WAS ADMITTED ON THE SAME DAY FOR FURTHER EVALUATION. AT THE TIME OF AN EVENT THE SUBJECT WAS ON ASPIRIN, WHICH WAS CONTINUED. THE 90% IN STENT RESTENOSIS AT THE MID RCA WAS TREATED BY OTHER DEVICES. THE RESIDUAL STENOSIS WAS 20% AND TIMI FLOW WAS 3. ON (B)(6) 2024, LAB TEST REVEALED ATRIAL FIB RVR CONSIDERED UNRELATED TO THE STENT, FOR WHICH HOSPITALIZATION WAS PROLONGED, AND WHICH WAS TREATED WITH MEDICATION. THE ISR WAS CONSIDERED TO BE RESOLVED/RECOVERED, AND THE SUBJECT WAS DISCHARGED WITH DAPT. IT WAS FURTHER REPORTED THAT ON (B)(6) 2024, THE SUBJECT STARTED EXPERIENCING EXERTIONAL MID CHEST TIGHTNESS. CORONARY ANGIOGRAPHY REVEALED 90% ISR AT THE MID RCA AND REVASCULARIZATION WAS RECOMMENDED. THE ISR WAS TREATED WITH A 3.5 MM X 15.0 MM EMERGE BALLOON, A 4.0 MM X 8.0 MM NC EMERGE, A 4.0 MM X 12.0 MM NC EMERGE AND A 4.0 MM X 12.0 MM AGENT DCB.

    Description of Event or Problem · 0

    AGENT IDE. IT WAS REPORTED THAT RESTENOSIS OCCURRED. ON (B)(6) 2022, THE SUBJECT PRESENTED WITH UNSTABLE ANGINA AND THE MID RCA WAS TREATED WITH 4.0 MM X 12 MM SYNERGY DRUG ELUTING STENT. ON (B)(6) 2024, THE SUBJECT WAS DIAGNOSED WITH IN STENT RESTENOSIS (ISR) AND WAS ADMITTED ON THE SAME DAY FOR FURTHER EVALUATION. AT THE TIME OF AN EVENT THE SUBJECT WAS ON ASPIRIN, WHICH WAS CONTINUED. THE 90% IN STENT RESTENOSIS AT THE MID RCA WAS TREATED BY OTHER DEVICES. THE RESIDUAL STENOSIS WAS 20% AND TIMI FLOW WAS 3. ON (B)(6) 2024, LAB TEST REVEALED ATRIAL FIB RVR CONSIDERED UNRELATED TO THE STENT, FOR WHICH HOSPITALIZATION WAS PROLONGED, AND WHICH WAS TREATED WITH MEDICATION. THE ISR WAS CONSIDERED TO BE RESOLVED/RECOVERED, AND THE SUBJECT WAS DISCHARGED WITH DAPT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1796731 SYNERGY XD CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Required Intervention