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); Paresis (1998); Visual Impairment (2138); Encephalitis (2429); Epilepsy (4407); Ischemia Stroke (4418)

Event Date 07/10/2023

Event Type  Injury  

Manufacturer Narrative

Continuation of d10: product id: unk-nv-echelon (unknown); implant date n/a; explant date n/a.Product id: unk-nv-marathon (unknown); implant date n/a; explant date n/a.G2: citation: authors: zhang b, qi j, chen p, et al.Deliberately staged combined endovascular embolization and subsequent microsurgery resection for the treatment of cerebral arteriovenous malformations.World neurosurgery 178:e254-e264 2023.Doi:10.1016/j.Wneu.2023.07.040.Earliest date of publication used for date of event.No unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.Without return of the product no definitive conclusion can be made regarding the clinical observations.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.

Event Description

Zhang, b., qi, j., chen, p., sun, b., ling, y., wu, q., xu, s., wu, p., & shi, h.(2023).Deliberately staged combined endovascular embolization and subsequent microsurgery resection for the treatment of cerebral arteriovenous malformations.World neurosurgery, 178, e254¿e264.Https://doi.Org/10.1016/j.Wneu.2023.07.040.Medtronic literature review found reports of subarachnoid hemorrhage, cerebral infarction, intracranial infection, epilepsy, right hand hemiplegia, and visual field deficits in association with marathon catheter, echelon catheter, and onyx use in endovascular embolization.The research supported good safety and efficacy for the avm treatment used.The purpose of this article was to determine the efficacy in endovascular embolization and microsurgery resection of arteriovenous m alformations.The authors reviewed 30 cases of patients treated for ruptured or non-ruptured cerebral arteriovenous malformations using a marathon catheter, echelon catheter, and onyx in an endovascular embolization.Of the 30 patients, the average age was 37 years, 12 were female and 18 were male.The article does not state any technical issues during use of onyx.There was however, a microcatheter perforation with a microcatheter; it was not specified whether it was the marathon or echelon catheter.In addition, 26 patients had mrs score of 0-2 at follow up.The following intra- or post-procedural outcomes were noted: 1.Subarachnoid hemorrhage including due to microcatheter perforation 2.Cerebral infarction 3.Intracranial infection 4.Epilepsy 5.New focal neurological deficits.5a.Right hand hemiplegia.5b.Visual field deficits.

• 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: 18130594
• MDR Text Key: 328038840
• Report Number: 2029214-2023-02205
• Device Sequence Number: 1
• Product Code: MFE
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 11/14/2023

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: 11/08/2023
• Initial Date FDA Received: 11/14/2023
• 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