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); Swelling/ Edema (4577)

Event Date 04/05/2017

Event Type  Death  

Event Description

Poncyljusz, w., sawicki, m., lubkowska, k., & rac, m.(2017).Early outcomes and periprocedural complications of transarterial embolization of brain arteriovenous malformations with onyx®.Neurologia i neurochirurgia polska, 51(4), 277¿285.Https://doi.Org/1 0.1016/j.Pjnns.2017.03.006.Medtronic review of the literature article found a review of 54 patients who underwent 108 embolization procedure to treat brain arteriovenous malformation (bavm) between 2006 and 2013.The aim of the study was to assess the efficacy and safety of endovascular treatment of bavm with onyx.Below are the adverse events reported in the article.Despite the noted adverse events, the conclusion of the article was that embolization of bavm with onyx is an effective and safe method of treatment but technique needs improvement to avoid the reported adverse events.1 patient death was reported in the article.In this case, the patient experienced subarachnoid hemorrhage (sah) due to tearing of a feeding pedicle during difficult retrieval of the trapped undetachable microcatheter (marathon).The sah induced cerebral edema that was resistance to treatment and the patient ultimately died.

Manufacturer Narrative

A2.Reported patient age (42 years) is representative of the mean age of all patient included in the study.A3.Reported patient sex (female) is representative of the majority of patient included in the study.Separate reports will be submitted for the serious injuries reported in the article.Associated with mdr #: 2029214-2023-01335 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: 17490988
• MDR Text Key: 320704278
• Report Number: 2029214-2023-01336
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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: 08/09/2023

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: 08/01/2023
• Initial Date FDA Received: 08/09/2023
• 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): Death
• Patient Age: 42 YR
• Patient Sex: Female