BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NC EMERGE

    MDR report key: 16765617 · Received April 18, 2023

    Report

    Report Number
    2124215-2023-18086
    Event Type
    Injury
    Date Received
    April 18, 2023
    Date of Event
    February 24, 2023
    Report Date
    April 18, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LOX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    AGENT IDE STUDY. IT WAS REPORTED THAT VASOSPASM OCCURRED. ON (B)(6) 2023, THE SUBJECT PRESENTED WITH CHIEF COMPLAINT OF UNSTABLE ANGINA, ABNORMAL STRESS AND KNOWN RESIDUAL STENOSIS OF THE LEFT ANTERIOR DESCENDING ARTERY. THE SUBJECT WAS DIAGNOSED WITH IN-STENT RESTENOSIS AND REFERRED FOR CARDIAC CATHETERIZATION. ON (B)(6) 2023, 70% IN-STENT RE-STENOSIS WITH THROMBOLYSIS IN MYOCARDIAL INFARCTION (TIMI) FLOW 3 AT THE PROXIMAL LEFT CIRCUMFLEX (LCX) WAS TREATED WITH LASER ATHERECTOMY AND A 3.50 MM X 20 MM NC EMERGE MONORAIL BALLOON CATHETER WHICH GOT RECOILED AND WAS UNABLE TO DILATE THE LESION OPEN. THE DIFFICULTY WAS CAUSED BY THE RESTENOTIC TISSUE AND PRIOR STENT IN THE TARGET LESION WHICH WAS TREATED BY DEPLOYING A 3.50 MM X 38 MM SYNERGY DRUG ELUTING STENT, SUCCESSFULLY. POST REVASCULARIZATION, 0% RESIDUAL STENOSIS WITH TIMI FLOW 3 WAS NOTED. THE EVENT WAS CONSIDERED TO BE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562421 NC EMERGE CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Required Intervention