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 Hematoma (1884); Intracranial Hemorrhage (1891); Rupture (2208); Swelling/ Edema (4577)

Event Date 04/20/2021

Event Type  Injury  

Manufacturer Narrative

Separate reports will be submitted for the other medtronic devices mentioned in the article: marathon microcatheter, apollo microcatheter, and mirage.008" guidewire a2.Reported patient age is representative of the average age of all patients included in the literature article study group.A3.Reported patient sex is representative of the majority of patient included in the literature article study group.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

Melo-guzman, g., mendizabal-guerra, r., burgos-sosa, e., nicolas-cruz, c.F., lara-torres, f., dommar-rodriguez, c.J., sanchez-garcia, l.M., villarreal-barrera, o.E., & ramirez-rodriguez, j.I.(2021).Neuro-hybrid treatment for definitive resolution of unrupture cerebral arteriovenous malformations.Interdisciplinary neurosurgery: advanced techniques and case management, 25.Https:// doi.Org/10.1016/j.Inat.2021.101215.Medtronic review of the literature article found a review of 35 cases of staged pre-embolization and subsequent microsurgical resection of unruptured cerebral arteriovenous malformations (avms).The study group included 35 patients who were treated at a single medical center between january 2010 and december 2018.In all included cases, patients underwent pre-embolization with onyx.Onyx was delivered via a marathon microcatheter or apollo microcatheter; it was not specified which catheter was used in each case.The microcatheters were navigated to the avm treatment location using a.008in mirage guidewire.There was no device malfunction or patient death reported in the article.Four complications related to embolization were recorded which consisted of rupture of the avm during the last embolization process.No patient merited an emergency surgical procedure.There were three immediate complications related to the surgery resection surgery: one patient presented an epidural hematoma on the same side of the craniotomy that required surgical drainage, with subsequent good evolution; another patient presented cerebral edema, which was reoperated to perform decompressive craniectomy, and another patient presented intracerebral hemorrhage treated with medical management.Three other patients had residual avm observed during follow-up after surgical resection and were sent for additional radiosurgery.It was noted that 9 patients had post-surgical neurological symptoms with mrs indicating moderate to severe disability.However, these patient symptoms/outcomes were determined by the authors to have a causal relationship to the patient index or other clinical conditions and not associated with the medtronic devices or the procedure.

• 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: 17633472
• MDR Text Key: 322082601
• Report Number: 2029214-2023-01502
• Device Sequence Number: 1
• Product Code: MFE
• Combination Product (y/n): N
• Reporter Country Code: MX
• 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: 08/28/2023

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: 08/15/2023
• Initial Date FDA Received: 08/28/2023
• 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
• Patient Age: 29 YR
• Patient Sex: Male