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); Rupture (2208)

Event Date 08/21/2023

Event Type  Death  

Manufacturer Narrative

A2.Reported patient age (60 years) is the average age for all patients included in the study group.A3a.Reported patient sex (male) is representative of the majority of patient in the study group.G3.The pma/501k reference number is unknown as the model of onyx used in the procedure was unknown.Separate reports will be submitted for the other possibly involved devices in these cases as well as for potentially serious injuries without outcome of death reported in the 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

Voldrich, r., charvát, f., & netuka, d.(2023).Copolymer liquid embolization of dural arteriovenous fistulas: a 20-year single-center experience.Journal of neuroimaging: official journal of the american society of neuroimaging, 33(6), 926¿932.Https://doi.Org/10.1111/jon.13148.Medtronic review of the literature article found a retrospective study which analyzed outcomes of endovascular treatment (evt) for dural arteriovenous fistulas (davfs).192 patients with 195 davfs were treated at the single facility between 2002 and 2023.Transarterial embolization with onyx was the preferred treatment strategy in majority of cases (92%) sometimes used with coils or n-butyl cyanoacrylate (nbca).Marathon microcatheters were used except in the cases of anterior fossa davfs embolized through anterior meningeal artery, in which cases a catheter with a detachable tip, either apollo or a non-medtronic catheter were used.A satisfactory clinical outcome of mrs score of less than 3 was achieved in 168 (88%) patients, and 181 (94%) patients showed clinical improvement or remained stable.No device malfunctions were reported.All patient with reported treatment of anterior fossa davf were considered cured and had improvement of modified rankin score (mrs).Six patients died as a result of intracranial hemorrhage (ich) from a ruptured malformation, with four of them experiencing complete embolization of the davf and two having undergone partial embolization.A new evt was planned for both patients who underwent partial embolization.In the meantime, however, rebleeding occurred, as a result of which both patients died.

• 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: 18720847
• MDR Text Key: 335579295
• Report Number: 2029214-2024-00298
• Device Sequence Number: 1
• Product Code: MFE
• Combination Product (y/n): N
• Reporter Country Code: EZ
• 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: 02/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2024
• 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): Death
• Patient Age: 60 YR
• Patient Sex: Male