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); Transient Ischemic Attack (2109); Dizziness (2194); Stenosis (2263); Vascular Dissection (3160); Unspecified Nervous System Problem (4426); Embolism/Embolus (4438); Thrombosis/Thrombus (4440)

Event Date 02/23/2023

Event Type  Injury  

Manufacturer Narrative

A2.Reported patient age (63 years) is representative of the mean age of all patients included in the study.A3.Reported patient sex (male) is representative of the majority of patients included in the study.Associated with mdr # 2029214-2023-00849 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

Zhou, c., cao, y.-z., jia, z.-y., zhao, l.-b., lu, s.-s., shi, h.-b., <(>&<)> liu, s.(2023).Endovascular recanalization of symptomatic chronic ica occlusion: procedural outcomes and radiologic predictors.Ajnr.American journal of neuroradiology, 44(3), 303¿310.Https://doi.Org/10.3174/ajnr.A7804 medtronic review of the literature article found a retrospective analysis of 47 patient with symptomatic chronic internal carotid artery occlusion (cicao) who underwent endovascular recanalization at a single facility from january 2018 to december 2021.Echelon microcatheters were used to access the occlusion sites for angiographic treatment with peripheral vascular devices.No device malfunctions associated with the echelon microcatheters were reported.It was noted that 35/47 patient achieved successful recanalization.Patient deaths reported in the article included: 2 patient deaths were reported in the article.1 patient died from massive reperfusion hemorrhage 1 day post-operative.1 patient, who did not achieve recanalization in the procedure and experienced recurrent stroke, died despite aggressive medical man agement.Serious intra-operative complications included: 2 patient who experienced asymptomatic dissection were treated with stent implantation.2 patients had distal embolization during the procedure and mechanical thrombectomy was completed successfully to address in both cases; neither of these patients experienced any new neurological symptoms or complications post-operatively.Serious post-operative complications included: 2 patients developed new neurologic symptoms 2 and 10 days after their procedures (their mrs scores were 2 and 4, respectively).Computed tomography perfusion (ctp) revealed significant hypoperfusion on the recanalization side, and computed tomography angiography (cta) showed in-stent thrombosis.The symptoms of both patients improved after emergency mechanical thrombectomy.1 patient had dizziness associated with restenosis during follow-up and received subsequent balloon dilation therapy.2 patients whodid not achieve recanalization in the index procedure experienced recurrent tia or stroke without mortality.Additional treatment/intervention was not described in the article.Non-serious adverse events included: 1 patient had a slight subarachnoid hemorrhage (sah) following vessel perforation with a guidewire.No additional symptoms or treatment were reported.1 patient who had asymptomatic dissection had no further treatment/action reported.3 patients were noted to have asymptomatic re-occlusion during follow with no further treatment/action reported.No additional adverse events or additional interventions were reported for 9/12 patients who did not achieve recanalization in the index procedures.

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.

Event Description

Additional information received reported the adverse events mentioned in this article are not directly related to medtronic 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: 17006169
• MDR Text Key: 315996996
• Report Number: 2029214-2023-00850
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K093750
• 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: 05/26/2023

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: 05/15/2023
• Initial Date FDA Received: 05/25/2023
• Supplement Dates Manufacturer Received: 05/15/2023
• Supplement Dates FDA Received: 05/26/2023
• 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 Age: 63 YR
• Patient Sex: Male