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

Model Number UNK-NV-MARATHON

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 10/29/2020

Event Type  Injury  

Manufacturer Narrative

Sweid a, el naamani k, sajja kc, et al.Incidence and predictors of ophthalmic artery occlusion in intra-arterial chemotherapy for r etinoblastoma.Journal of neurointerventional surgery.2021;13(7):652-656.Doi:10.1136/neurintsurg-2020-016759 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

Sweid a, el naamani k, sajja kc, et al.Incidence and predictors of ophthalmic artery occlusion in intra-arterial chemotherapy for r etinoblastoma.Journal of neurointerventional surgery.2021;13(7):652-656.Doi:10.1136/neurintsurg-2020-016759 medtronic literature review found a report of patient complications in association with a marathon catheter.The purpose of this article was to determine the incidence of ophthalmic artery (oa) occlusion in patients treated with selective ophthalmic artery catheterization (oac) for chemotherapy infusion for retinoblastoma.Also, to evaluate technical, anatomical, tumorous, and patient-related factors that are predictors of oa occlusion.The total study cohort included 208 retinoblastoma tumors of 208 eyes in 197 consecutive patients.The mean age of patients with thrombosis was 22.5 months, and 13 were male (65.5%).The article does not state any technical issues during use of the marathon catheter.The following intra- or post-procedural outcomes were noted: - there were 23 incidences of ophthalmic artery thrombosis (11.1%).

• 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: 15086061
• MDR Text Key: 296407668
• Report Number: 2029214-2022-01218
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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
• Date Manufacturer Received: 07/13/2022
• 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 Outcome(s): Other
• Patient Age: 22 MO
• Patient Sex: Male
• Patient Race: White