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

Model Number UNK-NV-ONYX

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

Patient Problems Fistula (1862); Headache (1880); Ischemia (1942); Muscular Rigidity (1968); Nerve Damage (1979); Dysphasia (2195); Rupture (2208); Foreign Body In Patient (2687)

Event Date 01/01/2021

Event Type  Injury  

Manufacturer Narrative

B3: date is approximate.Year is confirmed valid.G2: citation: authors: feng, a.Y., jin, m.C., wong, s., pepper, j.-p., jackler, r., <(>&<)> vaisbuch, y.Facial nerve paralysis following endovascular embolization: a case report and review of the literature.The annals of otology, rhinology, and laryngology 130(7):848-855 2021.Doi:10.1177/0003489420966611 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.

Event Description

Feng ay, jin mc, wong s, pepper j-p, jackler r, vaisbuch y.Facial nerve paralysis following endovascular embolization: a case report and review of the literature.The annals of otology, rhinology, and laryngology.2021;130(7):848-855.Doi:10.1177/0003489420966611 medtronic literature review found a report of patient complications in association with onyx liquid embolic.The purpose of this article was to report a case of facial nerve paralysis post-endovascular onyx embolization of a sigmoid sinus dural arteriovenous fistula (davf) from initial presentation to current management and discuss the merits of observation versus decompression through a systematic review of relevant literature.The patient¿s davf was embolized with onyx.Following the operation, the patient awoke with the ¿worst headache of [their] life¿ over the temporal-parietal area, accompanied by ipsilateral (right) peripheral facial palsy house brackmann (hb) grade 6, dysgeusia and self-reported hyperacusis (audiogram was normal).The surgery had been complicated by a transient right meningeal artery rupture, which was immediately embolized proximally with onyx during the same procedure, but still resulted in a minor left hemispheric infarct.At the 2-week post-treatment follow-up, the compound muscle action potential (cmap) showed reduced amplitude (<(><<)>50%) compared to the contralateral side.Blink reflex study revealed absent r1 and ipsilateral r2 responses with right supraorbital stimulation and absent contralateral r1 responses with left supraorbital stimulation.Electromyogram (emg) further demonstrated acute damage to the right facial nerve.Repeated angiogram showed residual right davf.Reviewing the post embolization ct scan, the onyx embolization particles were clearly seen at the geniculate segment of the facial nerve.Due to the absence of risk factors for stroke or any debilitating symptoms, conservative observation of the davf was chosen as the course of action.Furthermore, conservative management with botox chemodenervation and facial rehabilitation exercises for her facial palsy.At 3 months follow-up, facial movement improved to hb grade 4, and at 8 months follow-up, facial nerve function further improved to hb grade 2.At last follow-up (10 months post-operation), the patient reported significant subjective improvement, but still deals with mild synkinesis and tightness of the right face causing facial asymmetry, oral incompetence and an inability to perform bilabial sounds during speech.She currently continues with her conservative management.

• 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: 17715921
• MDR Text Key: 323147037
• Report Number: 2029214-2023-01637
• 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: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/08/2023

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: 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: 08/10/2023
• Initial Date FDA Received: 09/08/2023
• 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): Disability; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female