MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 ECHELON; CATHETER, CONTINUOUS FLUSH

Model Number UNK-NV-ECHELON

Device Problem Difficult to Advance (2920)

Patient Problems Coma (2417); Hydrocephalus (3272); Ischemia Stroke (4418)

Event Date 12/29/2023

Event Type  Injury  

Manufacturer Narrative

G2: citation: authors: wang, x., yu, j.Coiling of an iatrogenic aneurysm of the distal posterior inferior cerebellar artery via a marathon microcatheter.Interdisciplinary neurosurgery: advanced techniques and case: (b)(4).Doi:10.1016/j.Inat.2023.101950 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.See related reports #2029214-2024-00256, #2029214-2024-00257, and #2029214-2024-00258.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

Wang x, yu j.Coiling of an iatrogenic aneurysm of the distal posterior inferior cerebellar artery via a marathon microcatheter.Int erdisciplinary neurosurgery: advanced techniques and case management.2024;36.Doi:10.1016/j.Inat.2023.101950 medtronic literature review found a report of patient complications in association with axium coils, marathon microcatheter, and echeclon-10 microcatheter.The purpose of this article was to describe the case of a 60-year-old woman with an epidermoid cyst of the posterior fossa suffered subarachnoid hemorrhage (sah) after open surgery for the removal of an epidermoid cyst and fell into a coma.Digital subtraction angiography (dsa) was performed to detect the cause of sah and showed a dissecting aneurysm at the p3-4 segment junction of the  posterior inferior cerebellar artery (pica).Parent artery occlusion (pao) of the aneurysm was planned.Due to severe tortuosity of the pica and failure of repeated catheterizations of the aneurysm with an echelon-10 microcatheter and an sl-10 microcatheter, a marathon microcatheter over a synchro 10 guidewire successfully reached the aneurysm.Then, an axium prime 1 mm × 2 cm coil  was advanced easily and smoothly through a marathon microcatheter for a long distance.When the pusher wire of the coil encountered resistance, the coil was detached by a mechanical reliever.After removing the pusher wire, the synchro 10 guidewire continued to push the detached coil through the marathon microcatheter tip into the dissecting aneurysm, delivering it to its target location.Then, another prime 1 mm × 1 cm coil was deployed in the same way to complete the pao.The patient did not awaken postoperatively.On the 2nd day following evt, she suffered acute hydrocephalus, and an ommayacatheter with a reservoir was inserted into the frontal horn of the lateral ventricle.Cerebrospinal fluid was aspirated every day, 20 ml each time, twice a day.On the 7th day following evt, acute infarction with no mass effect of the cerebellar hemisphere was found on ct.Acute hydrocephalus was relieved, and aspiration of cerebrospinal fluid was stopped.Two weeks later, the patient was discharged but was still in a coma.During the follow-up period, no rebleeding occurred.Six months later, the patient did not wake up and was declared to be in a vegetative state.The following technical issues during use of the echelon and axium coils were noted: -repeated failed catheterizations with echelon-10 -pusher wire of the coil encountered resistance the following intra- or post-procedural outcomes were noted: -acute hydrocephalus -acute infarction -coma -vegetative state.

• Brand Name: ECHELON
• 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: 18672675
• MDR Text Key: 334947647
• Report Number: 2029214-2024-00259
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 02/08/2024

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?: Yes
• Device Operator: Health Professional
• Device Model Number: UNK-NV-ECHELON
• Device Catalogue Number: UNK-NV-ECHELON
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/02/2024
• Initial Date FDA Received: 02/08/2024
• 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; Disability; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female