BEUDAMED
    FDA Adverse Event Death Summary report: N

    FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM

    MDR report key: 22919851 · Received August 28, 2025

    Report

    Report Number
    2124215-2025-60503
    Event Type
    Death
    Date Received
    August 28, 2025
    Date of Event
    September 1, 2017
    Report Date
    August 28, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NFA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B2: THE EXACT DATE OF DEATH WAS NOT PROVIDED AND WAS ESTIMATED BASED ON THE EARLIEST KNOWN CAS PROCEDURE IN THE COHORT. B3: THE EVENT DATE WAS ESTIMATED TO THE EARLIEST KNOWN PROCEDURE INCLUDED IN THE COHORT. E1: (B)(6). DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. LI, B., FAN, W., YANG, Y., QU, X., TONG, J., LIU, Y., TAN, J., JIANG, W., & YU, B. (2022). PERI-PROCEDURAL VARIABLES AND OUTCOMES OF LONG-PERIOD HEMODYNAMIC INSTABILITY AFTER CAROTID ARTERY ANGIOPLASTY AND STENTING. VASCULAR, 31(5), 892-901. HTTPS://DOI.ORG/10.1177/17085381221091369.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LITERATURE THAT A PATIENT WHO UNDERWENT A CAROTID ARTERY STENTING (CAS) PROCEDURE USING A FILTER WIRE EZ DIED EVEN AFTER UNDERGOING EMERGENT PERCUTANEOUS CORONARY INTERVENTION (PCI) DUE TO MYOCARDIAL INFARCTION (MI). THE AIM OF THE STUDY WAS TO INVESTIGATE THE PERI-PROCEDURAL RISK FACTORS AND CLINICAL OUTCOMES ASSOCIATED WITH LONG-PERIOD HEMODYNAMIC INSTABILITY (HI) FOLLOWING CAROTID ARTERY STENTING (CAS). HEMODYNAMIC INSTABILITY, MANIFESTING AS HYPERTENSION, HYPOTENSION, OR BRADYCARDIA, IS A KNOWN COMPLICATION AFTER CAS; HOWEVER, ITS PROLONGED FORM-LASTING MORE THAN 24 HOURS-HAS NOT BEEN THOROUGHLY CHARACTERIZED IN TERMS OF PREDICTORS AND CONSEQUENCES. THE RESEARCHERS SOUGHT TO IDENTIFY WHICH PATIENT CHARACTERISTICS, PROCEDURAL TECHNIQUES, AND INTRAOPERATIVE VARIABLES WERE INDEPENDENTLY ASSOCIATED WITH THE DEVELOPMENT OF LONG-PERIOD HI. ADDITIONALLY, THEY EVALUATED SHORT-TERM CLINICAL OUTCOMES SUCH AS TRANSIENT ISCHEMIC ATTACK (TIA), STROKE, MYOCARDIAL INFARCTION, AND MORTALITY LINKED TO THIS CONDITION. THE STUDY INVOLVED 168 PATIENTS WHO UNDERWENT CAS BETWEEN (B)(6) 2017 AND (B)(6) 2020 AT A SINGLE ACADEMIC MEDICAL CENTER IN CHINA. THE AVERAGE AGE OF THE PARTICIPANTS WAS 68.2 YEARS, AND THE MAJORITY WERE MALE (81.5%). IN-HOSPITAL MORTALITY OCCURRED IN 1 PATIENT (0.8%) DESPITE UNDERGOING EMERGENT PERCUTANEOUS CORONARY INTERVENTION (PCI) DUE TO MYOCARDIAL INFARCTION (MI).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2837012 FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM TEMPORARY CORONARY SAPHENOUS VEIN BYPASS GRAFT FOR EMBOLIC PROTECTION NFA BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death