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

Model Number 105-5056

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

Patient Problems Anaphylactic Shock (1703); Vasoconstriction (2126); Vascular Dissection (3160)

Event Date 05/12/2020

Event Type  Injury  

Event Description

Sweid, a., hammoud, b., texakalidis, p., xu, v., shivashankar, k., baldassari, m.P., das, s., tjoumakaris, s., shields, c.L., anco na-lezama, d., lim, l.-a.S., dalvin, l.A., maamari, d.J., <(>&<)> jabbour, p.(2020).The use of alternative routes for the delivery of intra-arterial chemotherapy for retinoblastoma.Neurosurgery, 87(5), 956¿963.Https://doi.Org/10.1093/neuros/nyaa142.Medtronic review of the literature article found that 197 consecutive pediatric patients with 207 retinoblastomas underwent 658 intra-arterial chemotherapy (iac) procedures.The study subjects included patients with unilateral or bilateral intraocular retinoblastoma undergoing iac from february 2008 to june 2016.Alternative approaches to ophthalmic artery catheterization (oac) were, in total, 42 cases (6.4%)¿external carotid artery catheterization and use of ica balloon were performed in 22 (3.3%) and 20 (3%) cases, respectively.A mean of 3.1 iac cycles were performed for each patient.In total, there were 23 technical failures of the primary oac technique (3.4%).Periprocedural adverse events occurred in 4 procedures (0.6%).Use of an alternative technique for chemotherapy delivery other than selective oac in at least one iac cycle was not a predictor of enucleation.Success rate with iac was 97% (639).Of the total aborted cases, 2% (11) were because of an inability to catheterize the ophthalmic artery because of complete oa occlusion, atretic oa, stenotic oa, oa vasospasm, and unstable catheter position.1% (6) because of inability to catheterize the femoral artery.Alternative approaches to oac were, in total, 42 cases (6.4%) - eca catheterization and use of ica balloon were performed in 22 (3.3%) and 20 (3%) cases, respectively.In total, there were 23 technical failures of the primary oac technique (3.4%) (9 cases of oa occlusion, 10 cases of oa stenosis, and 4 encounters of unstable catheter position at the ostium).Periprocedural adverse events occurred in 4 procedures (0.6%): 2 vasospasms (1 oa following infusion of 5 ccs and one carotid vasospasm following straightening of a 360 loop), 1 ophthalmic segment internal carotid artery dissection, and one case of anaphylactic shock.Poor outcome defined as the need for enucleation surgery was documented in 58 (28%) patients.

Manufacturer Narrative

Reported patient age (24 months) is representative of the mean age of all patients included in the study.Reported patient sex (male) is representative of the majority (54.5%) of patients included in the study.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: 15077915
• MDR Text Key: 296346607
• Report Number: 2029214-2022-01209
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093750
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/21/2022

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: 105-5056
• Device Catalogue Number: 105-5056
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/13/2022
• Initial Date FDA Received: 07/21/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 24 MO
• Patient Sex: Male