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 Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2021

Event Type  malfunction  

Event Description

Sabino luzzi, mattia del maestro, renato galzio; acta neurochirurgica supplement; 2021; 132; the preoperative functional downgrading of brain avms; doi.Org/10.1007/978-3-030-63453-7_16.Medtronic received information in a literature article of a review of 31 patient's treated with onyx 18 and marathon catheters had complications.The average age was 36.9 and the male to female ration was 2.8.  thirty-one arteriovenous malformations (avms) were embolized in 51 endovascular procedures. only low-density onyx18 was used as the embolic agent in the present series.Through a transarterial transfemoral approach, a flow-directed microcatheter and a tapered mic roguidewire were advanced until the nidus.After a superselective catheterization of the main arterial feeders, a microcatheter was moved throughout the target feeders inside the nidus.While preferring the deep-seated parts, onyx was injected with a flow rate of 0.1 ml/s by means of the ¿plug and push¿ technique. the first session was always aimed to achieve the widest obliteration possible volume, stopping, however, after having reached the safest final possible result.Two mechanical and one hemodynamic endovascular complications were recorded during the embolization sessions; the mechanical ones both consisted of a catheter stuck, while a hemiparesis occurred in a single patient 8 h after the procedure. the estimated embolization-related morbidity rate was 3.2% with zero mortality. at the 6-month follow-up, the overall outcome was as follows: mrs 0¿2, mrs 3, and mrs > 4 in 77.5%, 19.3%, and 3.2% of the patients, respectively.Two patients (6.4%) had a small remnant, which underwent radiosurgery.As grade iii typing concerns, the best outcome was achieved in small and medium-deep avms.

Manufacturer Narrative

Related to report 2029214-2022-00434.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: 13815367
• MDR Text Key: 297411701
• Report Number: 2029214-2022-00435
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K093750
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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
• Initial Date Manufacturer Received: 03/03/2022
• Initial Date FDA Received: 03/18/2022
• 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 Age: 37 YR
• Patient Sex: Male