BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERIFLEX?

    MDR report key: 3921550 · Received July 9, 2014

    Report

    Report Number
    2134265-2014-03984
    Event Type
    Injury
    Date Received
    July 9, 2014
    Report Date
    June 10, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS 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

    IT WAS REPORTED THAT FOLLOWING A STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED AN ALLERGIC REACTION. IN (B)(6) 2012, THE PATIENT RECEIVED A VERIFLEX BARE METAL STENT. AN UNKNOWN PERIOD OF TIME LATER, THE PATIENT REPORTED BEING RUSHED TO THE EMERGENCY ROOM. THE PATIENT REPORTS SHE COULD NOT BREATHE, HAD "FLOWING UP WITH FLUIDS", MUCOUS IN THE LUNGS, BRONCHI AND NOSE. THE PATIENT REPORTED THIS CONDITION DID NOT EXIST PRIOR TO STENT PLACEMENT. THE PATIENT HAS A NICKEL ALLERGY. THE PATIENT IS CURRENTLY FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402155 VERIFLEX? STENT, CORONARY MAF BOSTON SCIENTIFIC - MAPLE GROVE H7493893412300 15484929

    Patients

    Seq Age Sex Outcome Treatment
    1 Other