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 Intracranial Hemorrhage (1891); Pseudoaneurysm (2605)

Event Date 07/30/2020

Event Type  Death  

Manufacturer Narrative

B3.Date of publication is used for reported event date.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

Patel, j., huynh, t.J., rao, d., & brzezicki, g.(2020).Vascular trauma in the head and neck and endovascular neurointerventional management.Journal of clinical imaging science, 10, 1¿9.Https://doi.Org/10.25259/jcis_96_2020.Medtronic review of the literature article found it reported a case series of patients who sustained traumatic arterial injury in the head and neck from both blunt and penetrating trauma with depictions of the interventions for each case.The article first reviewed vascular neck injuries, none of which reported use of a medtronic neurovascular devices in the treatment.The article then presented vascular head injuries.In case 2, a 55-year-old male patient had a fall resulting in blunt head injury with multicompartmental intracranial hemorrhage, including an expanding intraparenchymal hematoma caused by a pseudoaneurysm in the distal left anterior cerebral artery (aca) frontopolar branch.The patient underwent parent vessel embolization with onyx a the parent vessel was sacrificed.It was noted that this technique was used as other treatment was not considered feasible due to the distal location of the pseudoaneurysm and small caliber of the vessel.Unfortunately, despite craniectomy, pseudoaneurysm embolization, and intensive care, the patient's neurological status continued to decline and the patient died due to the presenting injuries.

• 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: 17783899
• MDR Text Key: 323866933
• Report Number: 2029214-2023-01781
• 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: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/20/2023

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: 08/22/2023
• Initial Date FDA Received: 09/20/2023
• 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): Death
• Patient Age: 55 YR
• Patient Sex: Male