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

Model Number UNK-NV-ONYX

Device Problem Entrapment of Device (1212)

Patient Problem Hearing Impairment (1881)

Event Date 05/19/2021

Event Type  Injury  

Event Description

Tashiro n., kawano h., hiraoka f., nakamura y., fukuda s., yano s., aikawa h., go y., kazekawa k., matsumoto m.Iatrogenic middle meningeal arteriovenous fistula during embolization: two case reports and literature review.Journal of stroke 2023.Doi: 10.1016/j.Jstrokecer literature review found reported of a defrictor microcatheter being partially trapped by the onyx solution.The patient developed pulsatile tinnitus in her left ear after the procedure.It was found that there was an irregular hyperintensity around the left middle meningeal artery in association with the transarterial embolization.The patient was brought back to the operating room on post operative day 3 for another endovascular procedure to treat the middle meningeal arteriovenous fistula to improve the patient tinnitus symptoms.  after the procedure, no findings indicative of neurological deficits were observed, and the patient¿s left tinnitus disappeared. the authors reviewed 1 case of a patient treated for middle meningeal arteriovenous fistula using onyx embolic agent.The patient was 46 year old female.  the following intra- or post-procedural outcomes were noted: 1) the defrictor catheter was partially trapped by the onyx.2) after the procedure, the patient became aware of pulsatile tinnitus in her left ear.Please see attached literature article.

Manufacturer Narrative

G2: citation: authors: tashiro n., kawano h., hiraoka f., nakamura y., fukuda s., yano s., aikawa h., go y., kazekawa k., matsumoto m.Iatrogenic middle meningeal arteriovenous fistula during embolization: two case reports and literature review.Journal of stroke 0.Doi: 10.1016/j.Jstrokecer.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: 17715330
• MDR Text Key: 323010401
• Report Number: 2029214-2023-01634
• Device Sequence Number: 1
• Product Code: MFE
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• 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

• Date FDA Received: 09/08/2023
• 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
• Date Manufacturer Received: 08/15/2023
• 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): Required Intervention