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

Model Number UNK-NV-ECHELON

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ischemia (1942); Muscle Weakness (1967); Paralysis (1997); Blurred Vision (2137); Loss of Vision (2139); Hydrocephalus (3272); Unspecified Nervous System Problem (4426)

Event Date 06/21/2021

Event Type  Injury  

Manufacturer Narrative

Qi y, sun y, wang y, et al.The application of ¿stilted building¿ technique in the embolization of aneurysms with secondary branches.Biomed research international.2021;2021:9976541.Doi:10.1155/2021/9976541.See manufacturer report # 2029214-2021-01566, 2029214-2021-01567, and 2029214-2021-01568 for other events mentioned in the article.If information is provided in the future, a supplemental report will be issued.

Event Description

Qi y, sun y, wang y, et al.The application of ¿stilted building¿ technique in the embolization of aneurysms with secondary branches.Biomed research international.2021;2021:9976541.Doi:10.1155/2021/9976541.Medtronic literature review found a report of patient complications in potentially association an echelon microcatheter, rebar catheter, and hyperglide balloon catheter.The purpose of this article was to evaluate the curative effect and safety of the ¿stilted building¿ technique, in which a larger diameter coil that is slightly larger than the diameter of the aneurysm was chosen to form a stable internal frame to support the sidewall of the aneurysm and the wall of the branch artery, resembling the pillars of the ¿stilted building¿ and providing a strong support point for the aneurysm to later be filled with coils.Twenty-five patients (18 female, mean age 63.5 years) were included in the retrospective study.All 25 patients successfully underwent aneurysm embolization.No aneurysms recurred among the patients who completed the follow-up.Three patients were considered to have perioperative complications, all of which were related to ischemic perforator arteries: one patient, with an aneurysm at the bifurcation of the right mca, developed right-sided facial paralysis and left limb weakness two weeks after surgery.Mri-dwi showed fresh infarction of the hind limb of the right internal capsule, no clear arterial occlusion, and blood flow restriction on dsa imaging review.A second patient, with a left posterior communicating aneurysm, showed decreased right limb muscle strength and reduced consciousness on the first postoperative day.Emergency reexamination of the brain ct showed no significant increase in hemorrhage or new infarcts.The patient¿s state gradually recovered after enhanced fluid perfusion.Considering possible small embolus shedding and vasospasm, the patient¿s consciousness was clear at the time of discharge, and the right limb muscle strength was grade 4.The last patient, with a left posterior communicating aneurysm, developed blurred vision and hemianopia on the right side but had normal limb movement 2 weeks after surgery.Reexamination of the brain ct showed left occipital lobe infarction, and dsa imaging showed that the blood flow of the left posterior communicating artery was restricted.Additionally, there were the following non-surgery-related complications: one patient, with an aneurysm of the sidewall of the m1 segment of the right mca, developed communicating hydrocephalus 12 months after surgery and underwent a lumbar cisternal-abdominal shunting.

Manufacturer Narrative

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

Additional information received reported this literature had been communicated with the surgeon in chaoyang hospital, and the adverse events mentioned in the article were not directly related to medtronic equipment/products.

• 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: 12943094
• MDR Text Key: 285574503
• Report Number: 2029214-2021-01569
• 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,Followup
• Report Date: 01/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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
• Date Manufacturer Received: 12/23/2021
• 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): Life Threatening; Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female