BEUDAMED
    FDA Adverse Event Death Summary report: N

    FILTERWIRE EZ?

    MDR report key: 4131313 · Received October 1, 2014

    Report

    Report Number
    2134265-2014-06177
    Event Type
    Death
    Date Received
    October 1, 2014
    Date of Event
    September 2, 2014
    Report Date
    September 3, 2014
    Manufacturer
    BOSTON SCIENTIFIC - SAN JOSE
    Product Code
    NFA
    PMA / PMN Number
    K061332
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE CAUSE OF PATIENT'S DEATH WAS AORTIC STENOSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FILTER BASKET FAILED TO DEPLOY AND PATIENT DEATH OCCURRED. THE TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS VESSEL OF THE SAPHENOUS VEIN GRAFT. A 190 CM FILTERWIRE EZ¿ WAS USED TO TREAT THE TARGET LESION. DURING PROCEDURE, THE DEVICE COULD NOT ADVANCE TO THE SECOND LESION, SO THEY TREATED THE FIRST LESION. THEY ATTEMPTED TO DEPLOY THE FILTER HOWEVER; THEY HAD DIFFICULTY PULLING THE DELIVERY SHEATH. THIS IS THE TIME THE PATIENT STARTED TO DETERIORATE. THE WHOLE SYSTEM WAS REMOVED FROM THE PATIENT AND CPR WAS DONE. HOWEVER THE PATIENT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611900 FILTERWIRE EZ? TEMPORARY CORONARY SAPHENOUS VEIN BYPASS GRAFT FOR EMBOLIC PROTECTION NFA BOSTON SCIENTIFIC - SAN JOSE H749201001900 16988221

    Patients

    Seq Age Sex Outcome Treatment
    1 Death