MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 MARATHON; CATHETER, CONTINUOUS FLUSH

Model Number UNK-NV-MARATHON

Device Problem Difficult to Remove (1528)

Patient Problems Intracranial Hemorrhage (1891); Rupture (2208); Unspecified Nervous System Problem (4426)

Event Date 02/10/2022

Event Type  Injury  

Event Description

Ahmed sultan, tamer hassan, and tamer ibrahim metwaly; interventional neuroradiology; 2022; 1-8; angiographic predictors of spontaneous obliteration of transarterial partially embolized brain arteriovenous malformations; medtronic received information in a literature article that patients treated with onyx embolization, marathon and apollo catheters, and mirage guidewires had complications.The study operators experienced obliteration of the nidus after unintended partial or subtotal embolization in some their cases of embolization.Those cases were fortunately discovered on follow-up.The study is discussing the possible underlying factors standing behind this phenomenon.It was a retrospective study of 140 patients that underwent embolization for cerebral arteriovenous malformations (avms) from 2005 to august 2019 using liquid embolic agents.  sixty-one (43.57%) patients weretreated by n-butyl cyanoacrylate and 71 (50.71%) patients were treated with onyx, and both materials were used together in 8 cases.Patient cohort included 74 (53%) females and 66 (47%) males.Their age ranged from 7 to 43 years old with about one-third of patients less than 18 years.Procedure: the femoral artery approach was used in all cases.General anesthesia with endotracheal intubation was used in all cases.A 6-f guiding catheter was used.To guard against blood clotting inside the guiding catheter, continuous flushing of normal saline was used. superselective navigation of the avm feeders was done using flow-directed microcatheters after complete cerebral angiography.The embolizing agent was chosen according to the angioarchitecture of the nidus.Onyx 18 was used in lesions with multiple compartments and feeders with enough length for the reflux of embolizing material.Onyx was slowly injected into the nidus under continuous roadmap fluoroscopy using the ¿push and plug¿ technique.If any reflux along the microcatheter was observed or the material reached the draining vein, the injection was stopped for 1¿2 min and then resumed to redirect onyx to different parts of the lesion.Control angiographies were done regularly during onyx injection to assess the nidus filling and the venous drainage.A dmso-compatible delivery microcatheter was used including marathon, apollo, or sonic.Microwires included mirage and hybrid.Results: the rate of complete occlusion in all patients was 61.43% (86 patients).There were three groups of patients, the first group had complete occlusion of the nidus at the time of embolization and included 68 (48.57%) patients.The second group had partial embolization with partial occlusion of the nidus 54 (38.57%).The 3rd group included 18 (12.85%) patients with complete nidal occlusion on follow-up after being partially embolized.The encountered complications included 6 cases of intraoperative rupture resulted in 4 cases of subarachnoid hemorrhage sah and 2 cases of parenchymal hemorrhage that required evacuation.Also, there were 5 cases of microcatheter trapping.The resulting morbidity included 7 cases with transient deficits and 2 cases of permanent neurological deficits.

Manufacturer Narrative

See attachments for literature article.Event related to the regulatory reports: 2029214-2023-01218 and 2029214-2023-01219 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: MARATHON
• Type of Device: CATHETER, CONTINUOUS FLUSH
• 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: 17415984
• MDR Text Key: 320132808
• Report Number: 2029214-2023-01220
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: EG
• 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: 07/28/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: UNK-NV-MARATHON
• Device Catalogue Number: UNK-NV-MARATHON
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/21/2023
• Initial Date FDA Received: 07/28/2023
• 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 Sex: Female