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 Problems Hematoma (1884); Intracranial Hemorrhage (1891); Nervous System Injury (2689)

Event Date 09/01/2023

Event Type  Injury  

Manufacturer Narrative

A separate report will be submitted for echelon 10 microcatheter reported in this literature article.A2.Reported age (70 years) is the approximate average age from all patients included in the literature article study group.A3.Reported patient sex (male) is the sex of the majority of patients in the literature article study group.A5b.Reported patient race (white) is representative of the majority of patients in the literature article study group.G4.As the model information of the onyx was not reported in the article, the pma/501k reference cannot be known.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

Weinberg, j.H., akhter, a., zakeri, a., tanweer, o., zyck, s., tjoumakaris, s., jabbour, p., kan, p., peng, j., & youssef, p.(2023).Middle meningeal artery embolization for membranous versus nonmembranous subdural hematomas: a retrospective and multicenter cohort study.World neurosurgery, 177, e680¿e685.Https://doi.Org/10.1016/j.Wneu.2023.06.122.Medtronic review of the literature article found a multicenter retrospective cohort study of 99 patients who underwent 117 middle me ningeal artery (mma) embolization procedures to treat subdural hematoma (sdh) at three facilities between (b)(6) 2019 and (b)(6) 2021.The study "aimed to determine whether mma embolization is more efficacious for sdhs with radiographically visible membranes." of the study group, 58 patients were noted have known chronic sdh and 14 patient were noted to have "acute on chronic" sdh.Mma embolization procedures were performed via transradial or transfemoral approach with a 5f access system and catheterization of the mma using a microcatheter.The echelon 10 was given as an example of a type of microcatheter used but it was not indicated that this was the catheter used in all procedures.Superselective angiography was performed and subsequent embolization of the frontal and parietal branches was performed using either onyx, non-medtronic particles, non-medtronic polyvinyl alcohol particles, coils (unspecified manufacturer/type), or a combination of treatment devices.It was not specified how many patient underwent treatment with each type of device or which outcomes occurred with which treatment type.No device malfunctions or patient deaths were reported in the article.Of all the procedures/patients in the study, it was noted that there were: - 7 experiences of unspecified complication.- recurrence of sdh occurred in 15 cases and 7 underwent retreatment.

• 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: 18582510
• MDR Text Key: 333773677
• Report Number: 2029214-2024-00161
• 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: 01/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2024
• 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
• Date Manufacturer Received: 01/19/2024
• 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): Other; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Race: White