BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGENT

    MDR report key: 20051815 · Received August 23, 2024

    Report

    Report Number
    2124215-2024-52797
    Event Type
    Injury
    Date Received
    August 23, 2024
    Date of Event
    July 27, 2024
    Report Date
    August 23, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OOB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A DISSECTION OCCURRED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE (CAD) FOR A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA). A 2.75 MM X 15.00 MM AGENT DCB WAS USED AT THE LEFT CIRCUMFLEX ARTERY (LCX). DURING THE ANGIOPLASTY, DISSECTION WAS NOTED AT THE PROXIMAL PART OF THE VESSEL. A DRUG ELUTING STENT WAS DEPLOYED TO COVER THE DISSECTION AND SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO FURTHER PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1387779 AGENT DRUG-ELUTING PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY CATHETER OOB BOSTON SCIENTIFIC CORPORATION 3825 09292H23

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention