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 Unspecified Infection (1930)

Event Date 10/08/2021

Event Type  Injury  

Manufacturer Narrative

B.3.Please note that this date is based off of the date of publication of the article [or the date that the article was accepted for publication] as the event dates were not provided in the published literature.No specific device information provided.See attached literature article.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

Domingo, r.A., de biase, g., navarro, r., santos, j.L.M., rivas, g.A., gupta, v., miller, d., bendox, b.R., brinjikji.W., fox, w.C., huynh, t.J., tawk, r.G.Clinical and radiographic characteristics of sacral arteriovenous fistulas: a multicenter experience.J neurosurg spine.2022.36:487¿497.Doi: 10.3171/2021.5.Spine21119.Summary: available data on management of sacral arteriovenous fistulas (savfs) are limited to individual case reports and small series.Management includes observation, endovascular embolization, or surgical ligation, with no clear guidelines on the optimal treatment modality.The authors¿ objective was to report their multiinstitutional experience with management of savf patients, including clinical and radiographic characteristics and postprocedural outcomes.The electronic medical records of patients with a diagnosis of spinal arteriovenous fistula treated from january 2004 to december 2019 at the authors¿ institutions were reviewed, and data were summarized using descriptive statistics, including percentage and count for categorical data, median as a measure of central tendency for continuous variables, and interquartile range (iqr) as a measure of dispersion.A total of 26 patients with savfs were included.The median (iqr) age was 65 (57¿73) years, and 73% (n = 19) of patients were male.Lower-extremity weakness was the most common presenting symptom (n = 24 [92%]), and half the patients (n = 13 [50%]) reported bowel and bladder sphincter dysfunction.The median (iqr) time from symptom onset to treatment was 12 (5.25¿26.25) months.Radiographically, all patients had t2 hyperintensity at the level of the conus medullaris (cm) (n = 26 [100%]).Intradural flow voids were identified in 85% (n = 22) of patients.The majority of the lesions had a single identifiable arterial feeder (n = 19 [73%]).The fistula was located most commonly at the s1 level (n = 13 [50%]).The site where the draining vein connects to the pial venous plexus was seen predominantly at the lumbar level (n = 16 [62%]).In total, 29 procedures were performed: 10 open surgeries and 19 endovascular embolization procedures.Complete occlusion was achieved in 90% (n = 9) of patients after open surgery and 79% (n = 15) after endovascular embolization.Motor improvement was seen in 68% of patients (n = 15), and bladder and bowel function improved in 9 patients (41%).At last follow-up, 73% (n = 16) of patients had either resolution or improvement of the pretreatment intramedullary t2 signal hyperintensity.T2 hyperintensity of the cm and a dilated filum terminale vein are consistent radiographic signs of savf, and delayed presentation is common.Complete occlusion was achieved in almost all patients after surgery, and endovascular embolization was effective in 70% of the patients.Further studies are needed to determine the best treatment modality based on case-specific characteristics.Reported events: there was 1 procedural complication corresponding to a surgical site infection.

• 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: 17642609
• MDR Text Key: 322183705
• Report Number: 2029214-2023-01514
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/29/2023

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
• Initial Date Manufacturer Received: 08/03/2023
• Initial Date FDA Received: 08/29/2023
• 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