BEUDAMED
    FDA Adverse Event Death Summary report: N

    AGENT

    MDR report key: 18847355 · Received March 6, 2024

    Report

    Report Number
    2124215-2024-13753
    Event Type
    Death
    Date Received
    March 6, 2024
    Date of Event
    November 3, 2021
    Report Date
    March 20, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OOB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    AGENT DCB REGISTRY. IT WAS REPORTED THAT A PATIENT DEATH OCCURRED. ON (B)(6) 2021, THE SUBJECT PRESENTED WITH UNSTABLE ANGINA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. THE TARGET LESION WAS LOCATED IN LEFT MAIN CORONARY ARTERY EXTENDING UP TO THE PROXIMAL LEFT CIRCUMFLEX ARTERY WITH 80% STENOSIS AND WAS 35MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5 MM. THE TARGET LESION WAS TREATED WITH PRE-DILATATION USING 3.0 MM X 12 MM BALLOON FOLLOWED BY TREATMENT WITH 2.50 MM X 30 MM AGENT DRUG COATED BALLOON WITH RESIDUAL STENOSIS OF 20%. POST DILATATION WAS NOT PERFORMED. ON (B)(6) 2021, THE SUBJECT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. ON (B)(6) 2021, 293 DAYS POST INDEX PROCEDURE, THE SUBJECT DIED. IT WAS STATED THAT THE SUBJECT HAD BEEN TREATED WITH MEDICATION.

    Description of Event or Problem · 0

    AGENT DCB REGISTRY. IT WAS REPORTED THAT A PATIENT DEATH OCCURRED. ON (B)(6) 2021, THE SUBJECT PRESENTED WITH UNSTABLE ANGINA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. THE TARGET LESION WAS LOCATED IN LEFT MAIN CORONARY ARTERY EXTENDING UP TO THE PROXIMAL LEFT CIRCUMFLEX ARTERY WITH 80% STENOSIS AND WAS 35MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5 MM. THE TARGET LESION WAS TREATED WITH PRE-DILATATION USING 3.0 MM X 12 MM BALLOON FOLLOWED BY TREATMENT WITH 2.50 MM X 30 MM AGENT DRUG COATED BALLOON WITH RESIDUAL STENOSIS OF 20%. POST DILATATION WAS NOT PERFORMED. ON (B)(6) 2021, THE SUBJECT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. ON (B)(6) 2021, 293 DAYS POST INDEX PROCEDURE, THE SUBJECT DIED. IT WAS STATED THAT THE SUBJECT HAD BEEN TREATED WITH MEDICATION. IT WAS FURTHER REPORTED THE SUBJECT DIED DUE TO CARDIAC ARREST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116769 AGENT DRUG-ELUTING PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY CATHETER OOB BOSTON SCIENTIFIC CORPORATION 3825 02869H20

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Required Intervention| D