BEUDAMED
    FDA Adverse Event Death Summary report: N

    ULTRAFLOW HCP

    MDR report key: 6457925 · Received April 4, 2017

    Report

    Report Number
    2029214-2017-00360
    Event Type
    Death
    Date Received
    April 4, 2017
    Date of Event
    July 31, 2006
    Report Date
    October 17, 2017
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    KRA
    PMA / PMN Number
    K093750
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CITATION: BRAIN AVM EMBOLIZATION WITH ONYX. W.J.VAN ROOIJ, M. SLUZEWSKI, G. N. BEUTE ET. AL. BASED ON THE REPORTED INFORMATION, THERE IS NO EVIDENCE SUGGESTED THAT THE DEVICE WAS DEFECTIVE, BUT RATHER A PROCEDURE RELATED EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE AUTHOR OF THIS ARTICLE REGARDING THIS CASE. SHOULD IT BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED. MDR'S RELATED TO THIS ARTICLE: 2029214-2008-00257, 2029214-2017-00359, 2029214-2017-00360, 2029214-2017-00361, 2029214-2017-00362, 2029214-2017-00363, 2029214-2017-00364, 2029214-2017-00365, 2029214-2017-00366, 2029214-2017-00367 AND 2029214-2017-00368. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION DURING LITERATURE REVIEW THAT AFTER POST EMBOLIZATION CT SCAN SHOWED A LARGE HEMATOMA ADJACENT TO THE AVM. A RUPTURED WAS CAUSED BY MICROCATHETER OR GUIDEWIRE AT THE BEGINNING OF THE PROCEDURE. THE PATIENT DETERIORATED RAPIDLY AND DIED 5 HOURS LATER. IT WAS REPORTED THAT PATIENT WITH A 4.5 CM RIGHT FRONTOPARIETAL AVM (SPETZKER AND MARTIN GRADE III) BETWEEN (B)(6) 2000 AND (B)(6) 2005, 44 PATIENTS WITH BRAIN AVMS WERE EMBOLIZED WITH ONYX. THERE WERE 18 WOMEN AND 26 MEN WITH A MEAN AGE OF 42.4 YEARS (MEDIAN 44, RANGE 14-71 YEARS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238339 ULTRAFLOW HCP CATHETER, CONTINUOUS FLUSH KRA COVIDIEN (IRVINE) UNK NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Death