MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 ONYX AVM; AGENT, INJECTABLE, EMBOLIC

Model Number 105-7100-080

Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Visual Impairment (2138); Obstruction/Occlusion (2422)

Event Date 11/27/2012

Event Type  Injury  

Manufacturer Narrative

Associate with mdr #: 2029214-2023-01465 a separate report will be submitted for the echelon-10 microcatheter used in the second treatment procedure for this patient.B3.Earliest date of publication used for date of event medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Event Description

Urdaneta-moncada, a., feng, l., chen, j.(2013).Occlusion of a clival dural arteriovenous fistula using a novel approach through the foramen ovale. journal of neurointerventional surgery, 5(6), e46.Https://doi.Org/10.1136/neurintsurg-2012-010475.Rep medtronic review of the literature article found that a 69-year-old female patient was undergoing embolization to treat a high-grade clival dural arteriovenous fistula (davf) near the left posterior clinoid process supplied by meningeal branches of the bilateral m eningohypophyseal trunks with minimal contribution from the bilateral external carotid artery (eca) branches which for the past 9 months had been causing progressive proptosis, chemosis, ophthalmoplegia and visual loss in the right eye.It was noted that the receiving veins travelled through the dorsum of the clivus to the right side, connecting to the cortical veins and right superior ophthalmic vein (sov) through small dural channels.The right cavernous sinus, right facial vein and bilateral inferior petrosal sinuses were occluded at baseline.During the initial procedure, it was noted there was no direct access to the left clival vein so an attempt was made to recanalize the left inferior petrosal sinus via the left internal jugular vein.A marathon microcatheter was delivered to about 2mm from the venous pouch receiving the arteriovenous (av) shunt but no channel to the fistula was found by venography or probing with guidewires.Onyx-34 which was injected with the plug-and-push technique with the hope that the high pressure would open a channel to the venous pouch; however, this was not successful.Transarterial embolization was then attempted.The meningohypophyseal trunks of the bilateral internal carotid arteries (icas) were catheterized and embolized with onyx-34.Post-embolization angiograms showed a notable reduction in av shunting though there was residual av shunting from the recurrent lacerum branch of the left ica and small dural branches of the bilateral middle meningeal arteries (mmas).The procedure was terminated and the patient was monitored in hopes the remainder of the fistula would thrombose.However, the patient's symptoms persisted so she returned a month later for embolization of the left mma.An echelon-10 microcatheter was positioned into the origin of the left mma dural branch; the orbital branches were protected with a detachable coil.Onyx-34 was injected using the plug-and-push technique.Just as the onyx was approaching the fistula site, reflux into the orbital vessels, including the left ophthalmic artery, was noted.The procedure was aborted and the patient was started on dual antiplatelet treatment (dapt) which helped preserve vision in her left eye.After 1 month the patient demonstrated some improvement in her right ptosis and chemosis but she continued to have ophthalmoplegia and minimal vision in her right eye.Percutaneous access to the vein was considered.The patient returned for a third treatment under general anesthesia.A 20g 6in spinal needle was inserted through the left foramen ovale into the left meckel's cave, then into the venous pouch under biplane digital subtraction road mapping.Venogram confirmed the needle position in the target vein.The fistula was then embolized with onyx-24 until reflux was seen at the main feeding artery.A post-embolization angiogram showed complete obliteration of arteriovenous shunting.The patient had immediate improvement in her eye symptoms after the procedure.Her proptosis, ophthalmoplegia and chemosis completely resolved within 2 months and she recovered most of the vision in her right eye.A follow-up angiogram at 3 months showed durable occlusion of the davf.

• Brand Name: ONYX AVM
• Type of Device: AGENT, INJECTABLE, EMBOLIC
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 17607368
• MDR Text Key: 321803567
• Report Number: 2029214-2023-01466
• Device Sequence Number: 1
• Product Code: MFE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 105-7100-080
• Device Catalogue Number: 105-7100-080
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/27/2023
• Initial Date FDA Received: 08/23/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female