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 Stroke/CVA (1770); Headache (1880); Intracranial Hemorrhage (1891); Muscle Weakness (1967); Paresis (1998); Stenosis (2263)

Event Date 04/01/2011

Event Type  Injury  

Event Description

Koizumi s, shojima m, ishikawa o, hasegawa h, miyawaki s, nakatomi h, saito n.S-shaped distal access catheter supported microcatheter navigation into the lenticulostriate artery feeders of brain arteriovenous malformations.Interventional neuroradiology (2020).Vol.26(6) 725-732.Doi:10.1177/1591019920935275.  medtronic literature review found reported of patient complications in association with the use of onyx for brain arteriovenous malformations.  the purpose of this article was to describe the novel technique of navigating a flow-guided microcatheter into lenticulostriate artery feeders using the strong support provided by an s-shaped distal access catheter.They reviewed a retrospective cohort of brain arteriovenous malformations, in which lenticulostriate artery feeders were attempted to embolize.During the study period, a total of 44 embolization sessions were performed on 25 avm cases consisting of 12 males and 13 females, with an average age of 36 (8¿72 years).Of these 25 cases, 8 lsa feeders were present in 6 cases (24%).In two of those cases, the diameter of lsa feeders was so small that the risk of embolization did not seem to outweigh the benefits.Thus, the operator had given up catheterizing them from the beginning.The authors reviewed 4 cases of patients treated for brain arteriovenous malformations using onyx.Of the 4 patients, the average age was 34 years, 3 were female and 1 was male.  symptomatic infarction in the lenticulostriate artery territory and mild vasospasm occurred in two cases each, but they did not result in permanent neurological deficits.Newly formed infarctions in the lsa territory were detected in three cases: one was asymptomatic (case 3), whereas the other two were symptomatic (cases 1 and 4).In case 1, two infarctions in the centrum semiovale appeared after embolization.The anterior infarction was attributed to embolization because it was continuous with the glue.The posterior infarction was separate from the glue and was attributed to flow arrest caused by wedging of the intermediate catheter into the origin of the lsa.These infarctions caused mild weakness of the right hand, which completely resolved in one week.In case 3, a small asymptomatic infarction that was continuous with the glue appeared.In case 4, a moderate infarction appeared in the right centrum semiovale that was continuous with the glue.It was responsible for left hemiparesis, which completely resolved in one week.In case 4, minor subarachnoid hemorrhage, limited to the cortical sulci near the nidus, was detected on computed tomography after embolization.It was attributed to the perforation of other cortical arteries embolized in the same session and was responsible for a minor headache lasting for a few days without neurological sequalae.Arterial dissection was not detected on angiograms obtained after embolization.Vasospasm at the m1 segment was noted in two cases.Stenosis was 43% in case 1 and 23% in case 3.In both cases, stenosis was not responsible for flow restrictions.  the article does not state any technical issues during use of the onyx.  the following intra- or post-procedural outcomes were noted: infarctions.Weakness of the right hand.Left hemiparesis.Subarachnoid hemorrhage.Minor headache.Vasospasm.Stenosis.

Manufacturer Narrative

An associated report has been submitted under regulatory report # 2029214-2021-01441.Reported patient age (34 years) is representative of the mean age of all patients included in the study.Reported patient sex (female) is representative of the majority of patients included in this study.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: 12789203
• MDR Text Key: 285057558
• Report Number: 2029214-2021-01442
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2021
• 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: 10/21/2021
• 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: 34 YR
• Patient Sex: Female