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 Hemorrhage/Bleeding (1888)

Event Date 04/12/2021

Event Type  Injury  

Event Description

Abaunza-camacho, j.F., vergara-garcia, d., perez, f., benavides, c., caballero, a., torres, j., riveros, w.M.(2021).Emergent hybrid treatment of a ruptured scalp arteriovenous fistula with eyelid involvement: technical note.Journal of neurological surgery.Part a, central european neurosurgery, 82(5), 490¿493.Https://doi.Org/10.1055/s-0041-1723848.Medtronic review of the literature article found that a 19-year-old female patient presented at the emergency department with profuse facial hemorrhage from a 2cm laceration in the left orbitozygomatic region.The patient reported a 5 year history of an untreated vascular lesion in the left upper eyelid related to a trauma injury in the same region during childhood.The patient was tachycardic with normal blood pressure, and no neurological focal signs.2 units of red blood cells were administered and compressive dressings were applied.The patient was emergently taken to the neuroangiography suite where a left scalp arteriovenous fistula (avf) was identified and classified as a yokouchi type c avf which signified multiple avfs were actually involved and the case was unique due to the involved left eyelid.The patient underwent an onyx embolization of the middle meningeal, superficial temporal, and auricular posterior arteries.A 60% reduction in the total flow of the fistula and control of the hemorrhage was achieved.However, post-operatively, recurrent bleeding episodes from the patient's eyelid laceration were observed so the patient was again taken to the operating room and combined endovascular-microvascular treatment was performed.First, onyx embolization of the superior arterial branch from the left ophthalmic artery was completed with significantly decreased the shunt flow without compromising normal eye irrigation.After onyx embolization, microvascular resection of the scalp avf was achieved by excision and draining of the main vein.Post-operative angiography showed resolution of the scalp fistula.However, there was a small residual left eyelid avf.The patient had an excellent recovery with no visual deficit or new bleeding episodes.The patient was offered close follow-up for monitoring of the residual left eyelid avf.

Manufacturer Narrative

B3.Date of earliest 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.

• 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: 17740859
• MDR Text Key: 323332374
• Report Number: 2029214-2023-01699
• Device Sequence Number: 1
• Product Code: MFE
• Combination Product (y/n): N
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/13/2023

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/15/2023
• Initial Date FDA Received: 09/13/2023
• 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): Required Intervention
• Patient Age: 19 YR
• Patient Sex: Female