BEUDAMED
    FDA Adverse Event Death Summary report: N

    AGENT

    MDR report key: 23541114 · Received November 13, 2025

    Report

    Report Number
    2124215-2025-82559
    Event Type
    Death
    Date Received
    November 13, 2025
    Date of Event
    December 26, 2024
    Report Date
    February 4, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OOB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B2 DATE OF DEATH AND B3 DATE OF EVENT WERE ESTIMATED BASED ON DEATH REPORTED AS OCCURRING IN (B)(6) 2025. DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. BECAUSE THE PRODUCT IS UNKNOWN, WE ARE UNABLE TO PROVIDE THE UNIQUE IDENTIFIER (UDI) # AND OTHER SPECIFIC PRODUCT INFORMATION.

    Additional Manufacturer Narrative · 0

    B2 DATE OF DEATH WAS ESTIMATED BASED ON DEATH REPORTED AS OCCURRING IN (B)(6) 2025. DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. BECAUSE THE PRODUCT IS UNKNOWN, WE ARE UNABLE TO PROVIDE THE UNIQUE IDENTIFIER (UDI) # AND OTHER SPECIFIC PRODUCT INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DEATH OCCURRED. IN (B)(6) 2024, THE PATIENT PRESENTED WITH UNSTABLE ANGINA. HEPARIN OR OTHER ANTITHROMBOTIC MEDICATION WAS ADMINISTERED. THE PATIENT WAS ON A PRIOR REGIMEN OF ASPIRIN (>= 72 HOURS). THE TARGET LESION WAS LOCATED AT DISTAL LEFT ANTERIOR DESCENDING ARTERY (LAD) AND WAS 32 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5 MM. FOLLOWING PRE-DILATION USING A 2.50 MM X 15 MM BALLOON, THE LESION WAS SUCCESSFULLY TREATED WITH A 2.50 MM X 40 MM AGENT DCB DEVICE WITH 0% RESIDUAL STENOSIS AND TIMI FLOW 3. A LESION LOCATED AT MID RIGHT CORONARY ARTERY (RCA) WAS TREATED WITH A 3.50 MM X 20 MM AGENT DCB DEVICE. THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2025, THE PATIENT EXPIRED DUE TO UNKNOWN CAUSE. IT IS NOT KNOWN IF AN AUTOPSY WAS PERFORMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DEATH OCCURRED. IN (B)(6) 2024, THE PATIENT PRESENTED WITH UNSTABLE ANGINA. HEPARIN OR OTHER ANTITHROMBOTIC MEDICATION WAS ADMINISTERED. THE PATIENT WAS ON A PRIOR REGIMEN OF ASPIRIN (>= 72 HOURS). THE TARGET LESION WAS LOCATED AT DISTAL LEFT ANTERIOR DESCENDING ARTERY (LAD) AND WAS 32 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5 MM. FOLLOWING PRE-DILATION USING A 2.50 MM X 15 MM BALLOON, THE LESION WAS SUCCESSFULLY TREATED WITH A 2.50 MM X 40 MM AGENT DCB DEVICE WITH 0% RESIDUAL STENOSIS AND TIMI FLOW 3. A LESION LOCATED AT MID RIGHT CORONARY ARTERY (RCA) WAS TREATED WITH A 3.50 MM X 20 MM AGENT DCB DEVICE. THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2025, THE PATIENT EXPIRED DUE TO UNKNOWN CAUSE. IT IS NOT KNOWN IF AN AUTOPSY WAS PERFORMED. IT WAS FURTHER REPORTED THAT IN (B)(6) 2024, 24 DAYS POST PROCEDURE, PLEURITIC CHEST PAIN OCCURRED. THE PATIENT WAS HOSPITALIZED AND MEDICATION WAS GIVEN OR THE REGIMENT WAS ADJUSTED. THE EVENT WAS RESOLVED TWO DAYS LATER. STENT THROMBOSIS WAS ADJUDICATED PERTAINING TO THE DEATH OF UNKNOWN CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2141341 AGENT DRUG-ELUTING PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY CATHETER OOB BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Death