BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGENT

    MDR report key: 19337072 · Received May 16, 2024

    Report

    Report Number
    2124215-2024-30022
    Event Type
    Injury
    Date Received
    May 16, 2024
    Date of Event
    April 22, 2023
    Report Date
    June 5, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OOB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    AGENT IDE STUDY THE SUBJECT WAS RANDOMIZED INTO THE AGENT IDE STUDY ON (B)(6) 2022 AND THE INDEX PROCEDURE WAS PERFORMED ON THE SAME DAY. HEPARIN OR OTHER ANTITHROMBOTIC MEDICATION WERE ADMINISTERED AT THE TIME OF INDEX PROCEDURE. THE TARGET LESION WAS LOCATED AT THE MID RIGHT CORONARY ARTERY (RCA) AND WAS 25 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.25 MM. THE TARGET LESION WAS PREDILATED WITH 3.5 MM X 20 MM BALLOON ANGIOPLASTY AND A CUTTING BALLOON RESULTING IN 40% RESIDUAL STENOSIS AND THROMBOLYSIS IN MYOCARDIAL INFARCTION (TIMI) FLOW OF 3. FOLLOWING PRE-DILATION, THE LESION WAS TREATED WITH A 3.50 MM X 30 MM AGENT DCB STUDY DEVICE SUCCESSFULLY, WITH 10% RESIDUAL STENOSIS AND TIMI FLOW OF 3. ON (B)(6) 2022, THE SUBJECT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. ON 22- APR-2023, THE SUBJECT WAS DIAGNOSED WITH ANGINA PECTORIS. AT THE TIME OF THE EVENT THE SUBJECT WAS ON ASPIRIN AND CLOPIDOGREL. ON (B)(6) 2023, 436 DAYS POST INDEX PROCEDURE, DIAGNOSTIC CORONARY ANGIOGRAPHY WAS PERFORMED. ON (B)(6) 2023, 483 DAYS POST INDEX PROCEDURE, THE SUBJECT WAS HOSPITALIZED FOR FURTHER EVALUATION AND TREATMENT. FRACTIONAL FLOW RESERVE WAS PERFORMED AS DIAGNOSTICS AND CORONARY ARTERY BYPASS SURGERY (CABG) WAS PERFORMED TO TREAT FROM PROX RCA TO MID RCA. ON (B)(6) 2023, THE EVENT WAS CONSIDERED TO BE RECOVERED/RESOLVED AND THE SUBJECT WAS DISCHARGED ON THE SAME DAY. IT WAS FURTHER REPORTED, THAT ON (B)(6) 2022, THE SAME DAY OF INDEX PROCEDURE, ANGIOGRAPHY REVEALED 70% IN-STENT RESTENOSIS AT MID RCA PROMPTING AGENT DCB TREATMENT. ON (B)(6) 2023, ECHO REVEALED NO SIGNIFICANT VALVULAR ABNORMALITIES. ON (B)(6) 2023, THE SUBJECT PRESENTED TO THE HOSPITAL AND REPORTED STRESS-EXACERBATED CHEST PAIN FOR WHICH NITROGLYCERINE WAS ADMINISTERED. ON THE SAME DAY, DIAGNOSTIC CORONARY ANGIOGRAPHY REVEALED 80% IN-STENT RESTENOSIS AT PROXIMAL RCA AND 90% IN-STENT STENOSIS AT MID RCA RESULTING IN THE ANGINA PECTORIS DIAGNOSIS. ON (B)(6) 2023, 80% IN-STENT RESTENOSIS AT PROXIMAL RCA AND 90% IN-STENT STENOSIS AT MID RCA WAS TREATED BY CABG.

    Description of Event or Problem · 0

    AGENT IDE STUDY THE SUBJECT WAS RANDOMIZED INTO THE AGENT IDE STUDY ON (B)(6) 2022 AND THE INDEX PROCEDURE WAS PERFORMED ON THE SAME DAY. HEPARIN OR OTHER ANTITHROMBOTIC MEDICATION WERE ADMINISTERED AT THE TIME OF INDEX PROCEDURE. THE TARGET LESION WAS LOCATED AT THE MID RIGHT CORONARY ARTERY (RCA) AND WAS 25 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.25 MM. THE TARGET LESION WAS PREDILATED WITH 3.5 MM X 20 MM BALLOON ANGIOPLASTY AND A CUTTING BALLOON RESULTING INTO 40% RESIDUAL STENOSIS AND THROMBOLYSIS IN MYOCARDIAL INFARCTION (TIMI) FLOW OF 3. FOLLOWING PRE-DILATION, THE LESION WAS TREATED WITH A 3.50 MM X 30 MM AGENT DCB STUDY DEVICE SUCCESSFULLY, WITH 10% RESIDUAL STENOSIS AND TIMI FLOW OF 3. ON (B)(6) 2022, THE SUBJECT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. ON (B)(6) 2023, THE SUBJECT WAS DIAGNOSED WITH ANGINA PECTORIS. AT THE TIME OF THE EVENT THE SUBJECT WAS ON ASPIRIN AND CLOPIDOGREL. ON (B)(6) 2023, 436 DAYS POST INDEX PROCEDURE, DIAGNOSTIC CORONARY ANGIOGRAPHY WAS PERFORMED. ON (B)(6) 2023, 483 DAYS POST INDEX PROCEDURE, THE SUBJECT WAS HOSPITALIZED FOR FURTHER EVALUATION AND TREATMENT. FRACTIONAL FLOW RESERVE WAS PERFORMED AS DIAGNOSTICS AND CORONARY ARTERY BYPASS SURGERY (CABG) WAS PERFORMED TO TREAT FROM PROXIMAL RCA TO MID RCA. ON (B)(6) 2023, THE EVENT WAS CONSIDERED TO BE RECOVERED/RESOLVED AND THE SUBJECT WAS DISCHARGED ON THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453793 AGENT DRUG-ELUTING PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY CATHETER OOB BOSTON SCIENTIFIC CORPORATION 3827 00322H22

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Required Intervention| H