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 Headache (1880); Hematoma (1884); Intracranial Hemorrhage (1891); Memory Loss/Impairment (1958); Dysphasia (2195)

Event Date 02/01/2023

Event Type  Injury  

Event Description

Medtronic received information that a patient treated with onyx had recurrence/progression of index hematoma.Hematoma thickness increased in size compared to last head ct on 4-jan-2023.No new or worsening symptoms.Possibly related to device and procedure.No actions were taken.Baseline hematoma: location: frontal, parietal, temporal.Hematoma thickness 25mm.Midline shift: 10mm.Additional information was received that the patient did not have new or worsening symptoms.No actions were taken.Additional information was received that the outcome of the event was unknown.Additional information received reported that the patient experienced occasional migraine headaches, slurred speech, and short term memory loss.No additional treatment or hospitalization was given, and the events were noted as recovering/resolving.The events were not the result of a device deficiency, were not associated with a seizure, and the patient did not experience a decline in their mrs score.The site assessed the adverse events as possibly related to the device and procedure.Additional information was received that the onset date for slurred speech, memory loss, and headaches was updated to (b)(6) 2023, additional information was received that the outcome was recovered/resolved on 2023-jun-19.Additional information was received that the clinical events committee adjudicated this event as not related to the study device or mma embolization procedure.Additional information was received that the description was updated to recurrence/progression of index subdural hematoma.

Manufacturer Narrative

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: 18123164
• MDR Text Key: 328002905
• Report Number: 2029214-2023-02197
• Device Sequence Number: 1
• Product Code: MFE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/13/2023

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: B351575
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/16/2023
• Initial Date FDA Received: 11/13/2023
• 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): Other
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 60 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White