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 Problems Low Blood Pressure/ Hypotension (1914); Vasoconstriction (2126); Respiratory Insufficiency (4462)

Event Date 04/01/2014

Event Type  Injury  

Event Description

Kim, dannenbaum, lin, bretana, brown, and schefler; the journal of retinal and vitreous diseases; 2018; 38(7):1420¿1426; use of femoral artery ultrasound during intraarterial chemotherapy for children under 10 kg with retinoblastoma; 10.1097/iae.0000000000001713 medtronic received information that patients treated with marathon catheters and mirage guidewires had complications.The purpose of the study was to demonstrate the safety and efficacy of intraarterial chemotherapy (iac) in small infants (,10 kg) with retinoblastoma. fifty-nine injections were administered to 11 eyes of 6 patients (two male, four female) whose median age was 8.4 months and whose weights ranged from 7.5 to 9.6 kg at the time of the first iac. five patients had bilateral retinoblastoma, and one patient had unilateral retinoblastoma.All iac procedures were performed by one experienced neuro-interventionalist under general anesthesia.A 4-french arterial sheath was introduced into the femoral artery, followed by an intravenous injection of heparin (70¿75 iu/kg) for anticoagulation during the procedure.Then, the internal carotid artery was catheterized using a 4-french catheter (cook medical inc, bloomington, in).Sequential angiograms of the common carotid artery and internal carotid artery were taken for the visualization of the detailed angio-anatomy of the head and for the selective placement of the catheter at the ostium of the ophthalmic artery.A marathon microcatheter (medtronic, minneapolis, mn) and a mirage micro-guidewire (0.008 inches; medtronic) were inserted, and a super-selective injection was performed to confirm the flow from the ostium into the ophthalmic artery without causing significant reflux to the distal internal carotid artery. chemotherapeutic drugs were diluted in 20 to 30 ml of saline and delivered into the ophthalmic artery through a 1-ml micro-syringe in a pulsatile and repetitive manner over 30 minutes to ensure homogeneous drug delivery.  if the ophthalmic artery was not fully developed or the access angle from the internal carotid artery to the ostium of the ophthalmic artery was too acute, the ophthalmic branch of the ipsilateral meningeal artery was alternately used. a femoral angiogram was performed, and when a significant spasm was detected, 50 to 200 mg of nitroglycerin was administered.On completion of the procedure, t he femoral sheath was removed, and a manual compression was applied to the leg for hemostasis.Patients were admitted to the post-anesthesia care unit with the legs immobilized for 6 hours using a pediatric arm splint.Outcome: all 11 eyes have been salvaged (100%), and no eyes were lost to enucleation or external beam radiation therapy. all patients are alive with no known metastatic retinoblastoma.Procedure-related non-ocular complications such as neurologic impairment, seizure, stroke, cerebral, or femoral ischemia were not observed in this series. patient 6 had a neutropenic fever and temporary loss of lashes after her last iac.For patient 5, no palpable pulse was felt in the leg after her first procedure, although the leg was warm.Once the patient was transported to post-anesthesia care unit, pulses were readily recovered.The temporary loss of pulse was attributed to vasospasm.Transient bronchospasm with hypotension occurred in three patients (patients 1, 3, and 5) during the procedure, once each.Epinephrine (0.5¿1.5 mg/kg) was administered, and all bronchospasm was resolved within several minutes.Neutropenia were reported, 3 cases of grade 3 neutropenia were reported, and 2 cases of grade 4 occurred.There was one reported case of hospitalization because of neutropenia and fever.Nine of these neutropenic events occurred after tandem iac therapy.

Manufacturer Narrative

See attachments for literature article.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: 15142348
• MDR Text Key: 297037386
• Report Number: 2029214-2022-01283
• 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: 08/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2022
• 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): Life Threatening; Hospitalization
• Patient Age: 8 MO
• Patient Sex: Female
• Patient Weight: 9 KG