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 Device Embedded In Tissue or Plaque (3165)

Event Date 01/25/2014

Event Type  Injury  

Manufacturer Narrative

Continuation of d10: product id: unk-nv-marathon; product id: 103-0608; product id: unk-nv-onyx; g2: citation: authors: ahmed, a.Z.Endovascular venous approach in the treatment of ruptured intra-cerebral arterio-venous malformation.Egyptian journal of radiology nuclear medicine 45(2):439-441 2014.Doi:10.1016/j.Ejrnm.2013.12.010.Earliest date of publication used for date of event no unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.Without return of the product no definitive conclusion can be made regarding the clinical observations.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.

Event Description

Ahmed az.Endovascular venous approach in the treatment of ruptured intra-cerebral arterio-venous malformation.Egyptian journal of radiology nuclear medicine.2014;45(2):439-441.Doi:10.1016/j.Ejrnm.2013.12.010.Medtronic literature review found a report of patient complications in association with a marathon catheter, mirage guidewire, and onyx liquid embolic.The purpose of this article was to present a case that illustrates that in patients with ruptured small arteriovenous malformation (avm) having a single draining vein, transvenous treatment can be utilized to achieve occlusion resulting in avm cure.A 6f envoy angled guiding catheter was placed in the distal left internal cervical carotid and multiple trials through different left mca feeders to reach the nidus were attempted by a marathon catheter over a mirage 0.008 guidewire.They failed to reach the nidus due to tiny caliber and tortuosity of the (en passage) feeders.To start the embolization they changed the strategy to a venous approach.A marathon catheter over a mirage 0.008 guidewire was advanced retrogradely guided by a road map from the arterial access till it reached the foot of the draining vein.Injection of onyx 18 started by making a plug to occlude the vein completely permitting retrograde flow of onyx into the nidus.Injection stopped when the arterial feeders from the left mca started filling with onyx retrogradely, confirming nidus closure.Angiographic closure of the nidus was also confirmed through different arterial injections in different views.To avoid the risk of venous rupture during pulling on the microcatheter, it was cut flush at the neck entry after applying some traction and left in situ.The cut end retracted subcutaneously, and the patient was kept on aspirin 200 mg/day for 3 mo nths.The procedure went uneventful, and the patient recovery was smooth with no additional deficits.

• 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: 17401541
• MDR Text Key: 319831014
• Report Number: 2029214-2023-01186
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: EG
• 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: 07/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2023
• 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
• Date Manufacturer Received: 07/19/2023
• 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): Other
• Patient Age: 35 YR
• Patient Sex: Male