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 Atrial Fibrillation (1729); Cardiac Arrest (1762); Intracranial Hemorrhage (1891); Unspecified Infection (1930); Muscle Weakness (1967); Pulmonary Dysfunction (2019); Renal Failure (2041); Shock (2072); Tachycardia (2095); Stenosis (2263); Obstruction/Occlusion (2422); Cognitive Changes (2551); Heart Failure/Congestive Heart Failure (4446); Swelling/ Edema (4577)

Event Date 09/02/2021

Event Type  Injury  

Manufacturer Narrative

Event related to regulatory reports: 2029214-2022-02049 and 2029214-2022-02050.Medtronic is submitting this report to comply wit.H 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

Bing sun, hao chang, yasuo ding; the journal of craniofacial surgery; 2021; (33)e419-e421;cerebral vasospasm-left heart failure-cerebral infarction may be a potential pathophysiological mechanism of malignant cerebral vasospasm; doi: 10.1097/scs.0000000000008350 medtronic received information in a literature article of a patient treated with an echelon 10 microcatheter and two different types of axium coils having complications.The patient was a a 47-year-old woman with intracranial aneurysm rupture and hemorrhage.In the procedure the micro-catheter [echelon10] was inserted into the aneurysm.Six microcoils (axium prime 3d and axium qc, ev3) were selected to fill the aneurysm.Reexamination showed that the embolic aneurysm was no longer visible. no intracranial artery stent was placed in the intracranial blood vessel during the operation.The postoperative computed tomography (ct) of the patient showed extensive subarachnoid hemorrhage (sah).On the 8th day, ct showed that the intracranial sah was significantly absorbed than before.On the 4th postoperative day, the patient developed a fast heart rate.The electrocardiogram showed atrial fibrillation. brain natriuretic peptide (bnp) was 548.4 pg/ml and gradually increased to 979.47 pg/ml.Comprehensive data suggest that the patient has cardiac insufficiency.Control of the ventricle rate to prevent stroke. on the 11th postoperative day, the patient had a sudden decrease in consciousness and a decrease in the muscle strength of the right limb.Ct angiography showed severe stenosis and occlusion in the m2 segment of the left middle cerebral artery, and the distal branches were significantly sparser than the opposite side. the patient has a history of atrial fibrillation.Acute stroke is considered for this acute attack, but cv cannot be ruled out.Fasudil was injected intrathecally during the operation.Twelve days after the occurrence of cv, ct showed edema in the left cerebral hemisphere, the midline was in the middle, and the left lateral ventricle was slightly compressed.After acuteleft heart failure, the patient developed multifunctional failure, abnormal coagulation function, renal insufficiency, lung infection, shock, and finally respiratory and cardiac arrest.

• 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: 15912714
• MDR Text Key: 304790602
• Report Number: 2029214-2022-02051
• 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: 12/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2022
• 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: 11/23/2022
• 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): Required Intervention; Life Threatening; Hospitalization
• Patient Age: 47 YR
• Patient Sex: Female