BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN_NEUROVASCULAR_PRODUCT

    MDR report key: 2877299 · Received December 18, 2012

    Report

    Report Number
    0002954917-2012-00138
    Event Type
    Death
    Date Received
    December 18, 2012
    Date of Event
    February 16, 2012
    Report Date
    November 29, 2012
    Manufacturer
    CONCENTRIC MEDICAL
    Product Code
    NRY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT SOURCE - LITERATURE: SAN ROMÁN ET AL. STROKE (SPAIN) 2012. DOI: 10.1161/STROKEAHA.111.640011. PMA/510(K)# - K120961/ K122478. THE DEVICE IS NOT AVAILABLE TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    CONCLUSION: FOR ANTICIPATED PROCEDURAL AND PATIENT COMPLICATION AND PRESENCE OF PROCEDURAL/BODILY FLUID. THE DEVICE WAS NOT AVAILABLE FOR ANALYSIS. FROM THE INFORMATION PROVIDED THERE WAS NO INDICATION THAT THE DEVICE WAS NOT USED AS IN ACCORDANCE WITH THE LABELING OR THAT THIS CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. HEMORRHAGE AND DEATH ARE KNOWN AND ANTICIPATED COMPLICATIONS TO THESE TYPES OF PROCEDURES AND ARE NOTED IN THE LABELING. THEREFORE, IT WAS DETERMINED THAT THE REPORTED EVENT WAS AN ANTICIPATED PROCEDURAL AND PATIENT COMPLICATION. THE CAUSE OF DISTAL EMBOLIZATION IS THE PRESENCE OF PROCEDURAL FLUIDS (CLOT OR EMBOLUS) DURING THE PROCEDURE. THEREFORE, A PROBABLE CAUSE OF PRESENCE OF PROCEDURAL/BODILY FLUID WAS ASSIGNED TO THE REPORTED EVENT OF DISTAL EMBOLIZATION SINCE THE DEVICE PERFORMANCE WAS LIMITED DUE TO PRESENCE OF PROCEDURAL/BODILY FLUIDS.

    Description of Event or Problem · 1

    IT WAS REPORTED IN AN ARTICLE IN STROKE JOURNAL THAT FROM JANUARY TO DECEMBER 2010, 60 PATIENTS WITH ACUTE STROKE UNDERWENT MECHANICAL THROMBECTOMY WITH THE RETRIEVAL DEVICES TO TREAT OCCLUSION OF THE ANTERIOR AND VERTEBROBASILAR CEREBRAL CIRCULATION. IT WAS REPORTED THAT THER WERE 17 DEATHS, 7 SERIOUS BLEEDS, AND ONE SYMPTOMATIC DISTAL EMBOLIZATION THAT WAS CLINICALLY RESOLVED AT DISCHARGE OCCURRED. IT WAS NOT POSSIBLE TO IDENTIFY THE NUMBER OF PATIENTS INVOLVED IN THE REPORTED ADVERSE EVENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED IN AN ARTICLE IN STROKE JOURNAL THAT FROM (B)(6) 2010, (B)(4) PATIENTS WITH ACUTE STROKE UNDERWENT MECHANICAL THROMBOECTOMY WITH THE RETRIEVAL DEVICES TO TREAT OCCLUSION OF THE ANTERIOR AND VERTEBROBASILAR CEREBRAL CIRCULATION. IT WAS REPORTED THAT THERE WERE (B)(4) DEATHS, (B)(4) SERIOUS BLEEDS, AND ONE SYMPTOMATIC DISTAL EMBOLIZATION THAT WAS CLINICALLY RESOLVED AT DISCHARGE OCCURRED. IT WAS NOT POSSIBLE TO IDENTIFY THE NUMBER OF PATIENTS INVOLVED IN THE REPORTED ADVERSE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN_NEUROVASCULAR_PRODUCT CATHETER, THROMBUS RETRIEVER NRY CONCENTRIC MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| O