BEUDAMED
    FDA Adverse Event Death Summary report: N

    VERIFLEX¿

    MDR report key: 2991718 · Received March 6, 2013

    Report

    Report Number
    2134265-2013-01225
    Event Type
    Death
    Date Received
    March 6, 2013
    Date of Event
    October 18, 2012
    Report Date
    February 8, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATION AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID: 2134265-2013-01224. SAME PATIENT AS MDR ID: 2134265-2012-03227 AND 2134265-2012-02820. IT WAS REPORTED THAT SUBSEQUENT TO A STENTING TREATMENT PROCEDURE STENT THROMBOSIS OCCURRED AND THE PATIENT EXPIRED. IN (B)(6) 2011, THE PATIENT PRESENTED THROUGH EMERGENCY ROOM WITH CHEST PAIN AND ST SEGMENT ELEVATION. THE 100% OCCLUDED LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED DISTAL RIGHT CORONARY ARTERY (RCA). A 4.50X28MM VERIFLEX STENT WAS IMPLANTED AND THE FOLLOWING DAY A 4.50X32MM VERIFLEX STENT WAS IMPLANTED. THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY BY HELICOPTER AND RETURNED HOME AFTER APPROXIMATELY 26 DAYS IN THE HOSPITAL. IN (B)(6) 2012 THE PATIENT RETURNED TO THE HOSPITAL WITH CHEST PAIN AND STENT THROMBOSIS WAS DIAGNOSED. A CORONARY ARTERY BYPASS WAS PERFORMED AND THE PATIENT LEFT THE HOSPITAL IN (B)(6) 2012 WITH HOSPICE CARE. APPROXIMATELY 8 DAYS LATER THE PATIENT EXPIRED. IT WAS REPORTED THAT THE PATIENT HAD NOT BEEN COMPLIANT WITH PRESCRIBED MEDICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95684 VERIFLEX¿ STENT, CORONARY MAF BOSTON SCIENTIFIC - GALWAY H7493893432450 0013575561

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death| R