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 Hemorrhage/Bleeding (1888); Vasoconstriction (2126); Hydrocephalus (3272); Ischemia Stroke (4418)

Event Date 09/25/2023

Event Type  Injury  

Event Description

Author peter kan, md, department of neurosurgery, university of texas medical branch, 1005 harborside drive 5th floor, galveston, tx 77555, usa.Email: ptkan@utmb.Edu citation srinivasan, v.M., karahalios, k., colasurdo, m., rhodenheiser, e., scherschinski, l., lazaro t.T., cortez, g., gross, b.A., kühn, a.L., puri, a., winkler, e.A., catapano, j.S., akamatsu, y., thomas, a., hanel, r.A., wakhloo, a., jadhav, a.P., ducruet, a.F., albuquerque, f.C., kan, p.Transvenous embolization of dural arteriovenous fistulas through the galenic (deep venous) system: multicenter case series and meta-analysis.Operative neurosurgery.2023.Vol.25 (6), pp.489-498.Doi: 10.1227/ons.0000000000000873 summary: arteriovenous fistulas involving the deep venous system have often been treated with microsurgery or transarterial embolization.Increasing familiarity with transvenous navigation and improved endovascular access systems may facilitate transvenous embolization (tve) for these rare and challenging lesions.We performed a retrospective study of neurointerventional databases of 6 high-volume centers.We identified all cases of arteriovenous fistulas with deep transvenous embolizations for arteriovenous fistula.Details regarding demographics, fistula characteristics, treatment considerations, clinical outcomes, and fistula occlusion were obtained and analyzed.The meta-analysis used the same inclusion criteria.Seventeen cases of tve were identified.The most common reasons for tve included prior treatment failure with microsurgery (n = 2) or transarterial embolization (n = 3) or inaccessible arterial pedicles (n = 4).For patients with full clinical outcome data (n = 14), 2 patients had worsened modified rankin scale, 8 patients had no change, and 4 were improved at a median clinical follow-up of 3.5 months.Angiographic obliteration was achieved in 15/17 cases (88.2%).In 1 case, catheterization around a sharp turn in the basal vein of rosenthal could not be performed.In another case, despite successful tve, there was residual lesion which was treated 1 year later by microsurgical clipping and excision.Transvenous approaches for embolization of deep arteriovenous fistulas have become possible with modern endovascular catheter systems and liquid embolics.These lesions can be treated safely and effectively through endovascular approaches, which may spare patients the traversal of deep structures needed for microsurgical approaches to these regions.The outcomes of tve are comparable with published outcomes of microsurgical interruption.Reported events: 1.Patient 4 -a 54 year old male patient with ich/sah experienced a severe diffuse vasospasm and stroke.2.Patient 17 a 61 year old female (incidental/asymptomatic) experienced ivh with hydrocephalus ams.No specific device information provided.See attached literature article.

Manufacturer Narrative

B3: the date provided was the date that the article was published as no specific event date was 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.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: 18758426
• MDR Text Key: 336054585
• Report Number: 2029214-2024-00325
• 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: Physician
• Type of Report: Initial
• Report Date: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• 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
• Date Manufacturer Received: 02/08/2024
• 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): Hospitalization