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 Visual Impairment (2138); Dysphasia (2195); Rupture (2208); Pseudoaneurysm (2605); Ischemia Stroke (4418); Ruptured Aneurysm (4436); Thrombosis/Thrombus (4440)

Event Date 05/11/2022

Event Type  Injury  

Event Description

Yangyang zhou, qichen peng and shiqing mu; chinese neurosurgical journal; 2022; 8:29; effects of enterprise 2 stent-assisted coil embolization for wide-necked intracranial aneurysms; doi.Org/10.1186/s41016-022-00298-w medtronic received information in a literature article that patients treated with echelon 10 catheters had complications.The study analyzed the safety and efcacy of enterprise 2 (ep2) stent-assisted coil embolization for wide-necked intracranial aneurysms by examining stent-vessel apposition, operative complications, embolization outcomes, and clinical outcomes.They retrospectively reviewed the medical records of patients with wide-necked intracranial aneurysms who underwent enterprise 2 stent-assisted coiling at the study institution from november 2018 to october 2019. in total, 106 wide-necked aneurysms in 106 patients were treated with ep2 stent-assisted coil embolization.Procedure: all patients with unruptured aneurysms were required to take oral aspirin 100 mg per day and clopidogrel 75 mg per day for at least 5 days before the operation. all operations were performed under general anesthesia.After unilateral femoral artery puncture was performed using the modified seldinger technique, a 6 fr arterial sheath was placed.Angiography of the intracranial arteries was performed to identify the aneurysm and parent artery.A stent microcatheter (prowler plus select) was placed in the appropriate position at the distal end of the parent artery under microguide wire guidance.The coil microcatheter (echelon 10) was then advanced into the aneurysm.After the first coils were released through the microcatheter and the coil basket was well formed, the stent was completely released.The aneurysm was then filled with coils.In patients who underwent intraoperative vasoct (high-resolution contrast-enhanced cone-beam computed tomography), the stent was completely released before coil packing.Coiling was completed once in reoperative imaging indicated complete aneurysm embolization.Results: one hundred six stents were successfully implanted in 106 patients.All stents were successfully delivered to the aneurysm site and deployed for a technical success rate of 100%. one patient experienced aneurysmal rupture during anesthesia induction and underwent rapid simple coil embolization; when the microcatheter was withdrawn, the last coil prolapsed into the parent artery, and therefore, an ep2 stent was placed.Six patients developed cerebral infarction within the first 3 days of the operation.Infarction presented with varying degrees of the limb muscle weakness or speech impairment and was confirmed by computed tomography (ct) or magnetic resonance imaging.One patient experienced transient brain stem mass effect after the operation and presented with binocular diplopia and left gaze preference.Another developed a pseudoaneurysm at the femoral puncture site that ruptured and required repair; this patient recovered well.Deep vein thrombosis at multiple sites occurred in one patient with pre-existing atrial fibrillation.Complications did not significantly differ between the unruptured and ruptured aneurysm groups. all patients underwent clinical follow-up (mean 19.7 months).No deaths occurred.Seven patients experienced poor clinical outcomes (mrs score=3).Among these seven patients, two had aneurysms as unexpected findings and postoperative infarct complications; three patients with ruptured aneurysms had neurological deficits post-operatively (final mrs scores 3, 4, and 5, respectively); two patients had cerebral infarction before admission, manifested by decreased limb muscle strength (final mrs scores 3 and 4, respectively).Although the unruptured aneurysm group had fewer complications and better clinical outcomes than the ruptured aneurysm group, univariate analysis showed that these intergroup differences were not significant.

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.

• 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: 17853686
• MDR Text Key: 324724333
• Report Number: 2029214-2023-01915
• 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: 10/02/2023

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-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: 09/22/2023
• Initial Date FDA Received: 10/02/2023
• 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 Sex: Female