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

Model Number UNK-NV-ONYX

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Paresis (1998)

Event Date 07/31/2021

Event Type  Injury  

Event Description

Khorasanizadeh m, salih m, harris d, ogilvy cs.Technique to ¿trap¿ a segment of the middle meningeal artery for embolization of a carotid cavernous fistula: 2-dimensional operative video.Operative neurosurgery (hagerstown, md).2021;21(5):e444.Doi:10.1093/ons/opab273.Medtronic literature review found a report of patient complications in association with onyx.The purpose of this article was to present the case of a 47-yr-old woman with a history of diplopia, headaches, and sixth cranial nerve (cn-vi) palsy who presented with acute worsening of headache and ophthalmoplegia and rise of intraocular pressures.Angiography demonstrated a left indirect ccf (dural arteriovenous malformation) with multiple arterial feeders from the internal carotid artery as well as the middle meningeal artery (mma) (barrow type d).Transvenous approach was attempted first but was unsuccessful due to difficult access to the cavernous sinus.Thus, transarterial embolization through the mma feeding branches was planned.To avoid occluding distal branches of the mma by onyx, we coiled it distally.In addition, a scepter balloon was used proximally to prevent the reflux of onyx into potential collaterals to cranial nerves from proximal mma.After trapping a segment of the mma, onyx was injected into the ccf fistula through the small mma feeders.A postembolization arteriogram showed obliteration of the ccf.The patient developed mild left facial nerve paresis on the first postoperative day (thought to be related to partial embolization of tiny arteries in the facial canal) and started dexamethasone, which was resolving in the course of hospitalization.She remained neurologically stable, and was discharged on the third postoperative day.The following intra- or post-procedural outcomes were noted: mild left facial nerve paresis and treatment with dexamethasone.

Manufacturer Narrative

G2: citation: authors: khorasanizadeh, m., salih, m., harris, d., & ogilvy, c.S.Technique to ¿trap¿ a segment of the middle meningeal artery for embolization of a carotid cavernous fistula: 2-dimensional operative video.Operative neurosurgery (hagerstown, md.) 21(5):e444 2021.Doi:10.1093/ons/opab273.Earliest date of publication used for date of event no unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.Without return of the product no definitive conclusion can be made regarding the clinical observations.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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

• Brand Name: ONYX
• 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: 17641078
• MDR Text Key: 322156965
• Report Number: 2029214-2023-01510
• 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: 08/29/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: UNK-NV-ONYX
• Device Catalogue Number: UNK-NV-ONYX
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/08/2023
• Initial Date FDA Received: 08/29/2023
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR
• Patient Sex: Female