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 Insufficient Information (4580)

Event Date 01/18/2023

Event Type  Injury  

Manufacturer Narrative

B.3.Please note that this date is based off of the date of publication of the article as the event dates were not provided in the published literature.No specific device information provided.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

Krothapalli, n., patel, s., fayad, m., elmashad, a., killory, b., bruno, c., sussman, e., alberts, m., ollenschleger, m., kureshi, i., mehta, t.Outcomes of particle versus liquid embolic materials used in middle meningeal artery embolization for the treatment of chronic subdural hematoma.World neurosurg.2023.173:e27-e36.Doi: 10.1016/j.Wneu.2023.01.077.Summary: early evidence suggests that middle meningeal artery (mma) embolization is an efficacious minimally invasive neuroendovascular technique for the management of chronic subdural hematoma (csdh).Particle and liquid embolic materials are commonly used to embolize the mma; however, studies comparing the safety and outcomes between these 2 materials are limited.- methods: patients ¿18 years old who had mma embolization for csdh between july 15, 2020 and may 1, 2022 were retrospectively identified from a single-center database.The primary safety, radiation dosage, fluoroscopy time, and radiographic and clinical outcomes were compared between particle and liquid embolization.In a cohort of 116, 48 (41.38%) were treated with liquid embolic material and 68 (58.62%) were treated with particle.The median age of the cohort was 73 years in the particle group and 73.5 years in the liquid embolic group.There was no significant difference in radiation dose or duration among both groups.There was no reported mortality associated with the procedure.One patient experienced nondisabling ischemic stroke in the particle group.Based on imaging follow-up, 3 patients in the particle group and 1 in the liquid embolic group had asymptomatic recurrence.One patient in each group had symptomatic recurrence requiring hematoma evacuation.The index median size of hematoma was 12 mm in the particle group and 11 mm in the liquid embolic group.At approximately 1 month follow-up, the median size of hematoma reduced to 6 mm in both groups.- our series shows that liquid embolic and particle embolization are equally safe and effective among patients undergoing mma embolization for management of csdh.Reported events: one patient in each group had symptomatic recurrence requiring hematoma evacuation.Index median size of hematoma was 12 mm in the particle group and 11 mm in the liquid embolic group.At approximately 35 days follow-up in the particle group and 29 days follow-up in the liquid embolic group, the median size of hematoma reduced to 6 mm in both groups.

• 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: 17565453
• MDR Text Key: 321357414
• Report Number: 2029214-2023-01421
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/17/2023

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: 07/21/2023
• Initial Date FDA Received: 08/17/2023
• 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