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 Problems Pain (1994); Skin Discoloration (2074); Foreign Body In Patient (2687); Unspecified Nervous System Problem (4426)

Event Date 02/24/2023

Event Type  Injury  

Manufacturer Narrative

Event related to reg report: 2029214-2023-01016.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.

Event Description

Vijay madhukar mundhe, rakesh singh, neeraj singh, anil karapurkar, gireesh warawdekar, narayan deshmukh, jagdish reddy; neurology india; 2023; 71:135-9; delayed complication of a retained microcatheter during neurovascular intervention presenting as limb ischemia: a case report and literature review; doi:10.4103/0028-3886.370460 medtronic received information in a literature article that a patient treated with onyx and a marathon catheter had complication.A 54-year-old gentleman had two episodes of sudden-onset thunderclap headache with vomiting within 1 month.At presentation, his ct scan was normal, but the mri flair sequence showed hemorrhage in the fourth ventricle. digital subtraction angiogram (dsa) demonstrated high-flow av fistula at the cervicomedullary junction, supplied by a lateral medullary branch from the v4 segment of the right vertebral artery (va), with venous aneurysm and both caudal and cranial venous drainage.Complete obliteration of fistula was achieved using ethylene vinyl alcohol onyx-18 embolization agent through a marathon microcatheter by using the plug-and-push technique.Initial reflux was allowed for about 2 cm.The total duration of the injection was 35 min.At the end of the procedure, it was difficult to retrieve the catheter,possibly from refluxed onyx coupled with a longer injection time allowing precipitation and solidification of onyx.The microcatheter was left in situ to avoid the risk of catheter fracture or arterial injury.The catheter was detached at the groin while maintaining slight traction.  the patient received enoxaparin 40 mg and aspirin 75 mg per day for 1 week, followed by aspirin alone for 1 year. follow-up angiogram at 1 year did not show the fistula, and the detached catheter was undisplaced.Five years later, the patient presented with sudden onset of pain in the right lower limb with onset within 4 h.Examination showed that the right leg below the knee was pale and colder than the left leg.The arterial pulsation of dorsalis pedis and tibialis artery were not palpable.Arterial doppler showed a mobile catheter inside the femoral artery and thrombus in the superficial femoral (sfa) and popliteal artery.Computed tomography angiography (cta) confirmed the same findings.Emergency endovascular procedure for removal of thrombus and marathon microcatheter was planned.Angiogram was done through left femoral artery access with a 7f short sheath.It showed that the catheter was lying between aortic bifurcation and right superficial femoral artery with thrombosis of sfa and popliteal artery.Part of the marathon catheter in the aorta was pulled into the left common iliac artery with the help of a pigtail catheter and snare.Attempts to retrieve the catheter with snare and dormia failed probably because the tip was tightly lodged in the sfa.The pigtail catheter was taken over a double-length exchange wire into the distal superficial femoral artery.The snare was taken down inside the pigtail catheter.The lower end of the marathon catheter was engaged in the loop snare and pigtail catheter, and repeated twisting movements were performed and the distal end was finally pulled out along with the pigtail catheter up to aortic bifurcation.A snare was then used to catch the catheter at the aortic bifurcation.The snare and the entire length of the marathon microcatheter were taken out.Subsequent to successful retrieval, thrombus aspiration was performed.Post procedure, the patient recovered completely, and follow-up doppler at 3 months showed patent arterial vasculature.

• 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: 17252228
• MDR Text Key: 318439926
• Report Number: 2029214-2023-01017
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 07/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2023
• 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: 06/28/2023
• 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): Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male