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 Pulmonary Embolism (1498); Headache (1880); Intracranial Hemorrhage (1891); Perforation of Vessels (2135); Lethargy (2560); Unspecified Nervous System Problem (4426)

Event Date 09/08/2020

Event Type  Injury  

Manufacturer Narrative

This article was previously reported in manufacturer reports # 2029214-2022-00389 and 2029214-2022-00390.Koyanagi m, mosimann pj, nordmeyer h, et al.The transvenous retrograde pressure cooker technique for the curative embolization of high-grade brain arteriovenous malformations.Journal of neurointerventional surgery.2021;13(7):637-641.Doi:10.1136/neurintsurg-2020-016566.If information is provided in the future, a supplemental report will be issued.

Event Description

Koyanagi m, mosimann pj, nordmeyer h, et al.The transvenous retrograde pressure cooker technique for the curative embolization of high-grade brain arteriovenous malformations.Journal of neurointerventional surgery.2021;13(7):637-641.Doi:10.1136/neurintsurg-2020-016566 medtronic literature review found a report of patient complications in association with onyx and apollo and marathon catheters.The purpose of this article was to evaluate the cure rate and safety of the transvenous retrograde pressure cooker technique (rpct) using coils and n-butyl-2-cyanoacrylate as a venous plug for embolization of brain arteriovenous malformations (avms).Fifty-one patients (20 women; median age 47 years) were included.An unknown number of the 51 patients were treated using onyx and apollo catheters.Complete obliteration was observed in 49/51 patients.The article does not state any technical issues during use of the onyx or apollo or marathon catheters.  the following intra- or post-procedural outcomes were noted: postoperative intracranial hemorrhage occurred in three patients: the first was a patient with a ruptured dorsal midbrain avm that initially presented with ventricular bleeding.After an uneventful rpct and complete exclusion, the patient developed pulmonary embolism that was anticoagulated, followed by headaches and somnolence on the following day.A ct revealed an intracerebral hematoma in the left thalamus extending to the corona radiata and ventricular system, possibly precipitated by anticoagulation. the second bleed occurred in a patient with a right-sided basal ganglial avm who initially presented with putaminal hemorrhage and left hemiparesis.Venous perforation occurred during catheterization of a long and tortuous frontobasal vein.Nonetheless, prompt curative embolization could be achieved, including perforation site.Minimal subarachnoid contrast extravasation was observed on cone-beam ct, which remained clinically uneventful.The third happened in a hemiparetic patient with a four-time ruptured left-sided basal ganglial avm previously treated twice by stereotactic radiosurgery.Despite an uneventful curative rpct, a parenchymal hematoma with intraventricular extension requiring surgical evacuation developed 24 hours later.Recovery to his pre-operative status (mrs 4) was observed at 30 days.-five experienced at least 1-point mrs worsening at 30 days.At 1 year, two improved and regainedtheir pre-interventional condition (5.9% transient morbidity).One with a pre-mrs of 3 gradually decreased to 4 at 30 days and 5 at 1 year, despite any treatment-related ischemic or hemorrhagic changes.Clinical worsening was attributed to wasting syndrome.One with a pre-mrs of 1 increased to 2 at 30 days and 1 year and thus categorized as minor permanent morbidity.As a result, one major treatment-related complication (2%) was observed in our series.

• 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: 14781784
• MDR Text Key: 294660082
• Report Number: 2029214-2022-01044
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 06/22/2022

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: 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
• Initial Date Manufacturer Received: 06/20/2022
• Initial Date FDA Received: 06/22/2022
• 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): Disability; Required Intervention
• Patient Age: 47 YR
• Patient Sex: Male