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 Fistula (1862)

Event Date 03/07/2023

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.See attached literature article.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.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

Bahar, a., pranata, j., gunawan, a., soraya, g.V.Clinical characteristics, angiographic fndings and treatment outcomes of carotid cavernous fstula in makassar, indonesia: a single-centre experience.Egypt j neurol psychiatry neurosurg.2023.59:29.Doi: 10.1186 /s41983-023-00630-w summary: carotid cavernous fstula (ccf) is an abnormal arteriovenous shunt between the carotid artery or its branches, with the cavernous sinus.It is still common in developing countries, and is mostly due to traumatic origin.Endovascular treatment has emerged as the primary mode of treatment of ccf.This is the frst study describing the clinical manifestation, angiographic characteristic, and the challenges we face in endovascular treatment of ccf cases in makassar, indonesia.Results this descriptive study was conducted between january 2019 to march 2022.We reviewed medical records and angiograms of all patients diagnosed with ccf at the wahidin general hospital, makassar.Clinical manifestations, angiogram results, treatment, and outcome data were analyzed.A total of 23 patients were included in this study, with 17 (73.9%) direct ccf (barrow type a) and 6 (26.1%) indirect ccf (barrow type b, c, d).The mean age of patients were 32 years old.The three most common clinical manifestations were proptosis (n=21, 91.3%), headache (n=14, 60.8%), and chemosis (n=14, 60.8%).The three most common drainage routes were via the superior ophthalmic vein (n=23, 100%), inferior petrosal sinus (n=12, 52.1%), and superfcial middle cerebral vein (n=6, 26.0%).All patients with direct ccf (n=17) had endovascular treatment, resulting in 13 cases with complete occlusion (76.5%), 3 cases with incomplete occlusion (17.6%), and 1 (5.9%) procedu re cancelled due to difcult navigation.Occlusion of fstula was best achieved with detachable coil, with a technical success rate of 90%.In indirect ccf (n=6), 4 patients were treated conservatively and 2 with endovascular treatment, with complete occlusion in 2 patients.Carotid cavernous fstula patients commonly presented with orbital symptoms, headache, or neuroophthalmologic signs.The most common drainage pattern is via anterior route.Posterior, superior and lateral drainage were not found in indirect ccf.Endovascular treatment is an efective method for fstula closure, especially in the case of direct fstula.Challenges in endovascular treatment are related to the anatomy of the fstula and cavernous sinus.Reported events: endovascular treatment was performed using transarterial approach with evoh and in one patient combined with coil.The reason for the failure to achieve complete occlusion was difficulty of access, due to the feeder artery¿s small diameter.

• 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: 18196296
• MDR Text Key: 328896781
• Report Number: 2029214-2023-02277
• Device Sequence Number: 1
• Product Code: MFE
• Combination Product (y/n): N
• Reporter Country Code: ID
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/22/2023

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: 11/16/2023
• Initial Date FDA Received: 11/22/2023
• 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