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 Depression (2361)

Event Date 06/27/2020

Event Type  Injury  

Manufacturer Narrative

No specific device information provided.See attached literature article.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.

Event Description

Rao, s., giron, f.A rare case of a large, deceitfully quiet brainstem arteriovenous malformation presenting only as dizziness.Cureus.2020.12(6): e8870.Doi: 10.7759/cureus.8870.Summary: dizziness is one of the most frequent complaints encountered in the medical practice affecting 15%-20% of adults yearly, and can be challenging to assess.Most patients use dizziness as a non-specific term, and thus suffer prejudice from the physicians¿ end and can be disregarded frequently.Dizziness can be a symptom of various diseases, some with sinister pathologies.We present a case of garden-variety vertigo that unfurled to be not-so-simple, emphasizing the importance of a thorough history and physical examination again even in the era of technology.A 32-year-old male patient with no past medical history presented with dizziness, later clarified as gradually progressive vertigo for two years, with unstable gait, dysarthria, and occasional diplopia.Physical examination found sustained nystagmus that changed direction with horizontal gaze, vertical nystagmus with upward gaze, dysarthria, and a wide-based ataxic gait.Ct head without contrast revealed indeterminate hypodense areas in the left midbrain, pons, and cerebellar hemisphere.Mri brain identified a 2.8 x 3.4 x 4.2 cm spetzler-martin grade iv brainstem arteriovenous malformation (avm) involving the left midbrain, pons, and cerebellum.Feeders were mostly from the posterior circulation, with three intranidal aneurysms, all draining into the deep venous system.The avm was deemed inoperable, and the patient was treated with onyx embolization for two/three feeding vessel aneurysms.After treatment, the symptoms persisted, and the patient was diagnosed with major depressive disorder (mdd) six months after diagnosis, and was admitted a year later with suicidal ideation and substance use disorder.Brain avms are rare clinical entities that present in 0.1% of the population, mostly presenting as intracranial bleeds.When they do rarely present with isolated focal neurologic deficits, it has been attributed to a vascular steal phenomenon, hemorrhage, or a mass effect.The isolated findings of vertigo and dysarthria are highly non-specific; with such presentation, clinicians should consider etiologies under the realm of vertigo of central origin.An untreatable avm reduces patients¿ quality of life and has been linked to depression and anxiety, and thus patients may benefit from psychosocial therapy.Although preventing intracranial hemorrhage (ich) is the primary concern with brain avms, the rest of the patient¿s profile should not be forgotten.Reported events: the avm was deemed inoperable, and the patient was treated with onyx embolization for two of the three feeding vessel aneurysms.Even following the treatment, the symptoms persisted, affecting the patient¿s quality of life significantly.He was diagnosed with major depressive disorder (mdd) six months after the diagnosis and treatment and was admitted a year later with suicidal ideation and substance use.

• 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: 17754715
• MDR Text Key: 323493936
• Report Number: 2029214-2023-01726
• Device Sequence Number: 1
• Product Code: MFE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/15/2023

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
• Initial Date Manufacturer Received: 08/17/2023
• Initial Date FDA Received: 09/15/2023
• 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): Hospitalization