ONYX AVM 105-7000-060

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-02-17 for ONYX AVM 105-7000-060 manufactured by Micro Therapeutics, Inc. Dba Ev3.

Event Text Entries

[189088401] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[189088402] Medtronic received a report that the onyx liquid embolic was not clear in the fluoroscopic image. The speed setting was at 8 and shaken for 40 minutes. The vials did not sit for more than 5 minutes prior to injection, and the physician injected the onyx immediately after mixing. It was indicated that all devices were prepared as per the instructions for use (ifu), and no patient symptoms or further complications were reported as a result of this event. Post-op angiographic results were good. The patient was undergoing surgery for treatment of a dural arteriovenous fistula (davf). It was noted the patient's vessel tortuosity was moderate. Ancillary devices include a fubuki 8fr, envoy da 6fr, apollo microcatheter, chikai guidewire.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2029214-2020-00149
MDR Report Key9718548
Report SourceCOMPANY REPRESENTATIVE,DISTRI
Date Received2020-02-17
Date of Report2020-02-17
Date of Event2020-02-13
Date Mfgr Received2020-02-13
Device Manufacturer Date2019-04-16
Date Added to Maude2020-02-17
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactKATCHA TAYLOR
Manufacturer Street9775 TOLEDO WAY
Manufacturer CityIRVINE CA 92618
Manufacturer CountryUS
Manufacturer Postal92618
Manufacturer Phone9496801345
Manufacturer G1MICRO THERAPEUTICS, INC. DBA EV3
Manufacturer Street9775 TOLEDO WAY
Manufacturer CityIRVINE CA 92618
Manufacturer CountryUS
Manufacturer Postal Code92618
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameONYX AVM
Generic NameAGENT, INJECTABLE, EMBOLIC
Product CodeMFE
Date Received2020-02-17
Model Number105-7000-060
Catalog Number105-7000-060
Lot NumberA815960
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMICRO THERAPEUTICS, INC. DBA EV3
Manufacturer Address9775 TOLEDO WAY IRVINE CA 92618 US 92618


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-17

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