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 Intracranial Hemorrhage (1891); Rupture (2208); Thrombosis/Thrombus (4440)

Event Date 03/02/2022

Event Type  Injury  

Event Description

Hideki endo, yumiko mitome-mishima, kazumoto suzuki, kenji yatomi, kohsuke teranishi, hidenori oishi; clinical neurology and neurosurgery; 2022; (217) 107275; long-term outcomes of y-stent-assisted coil embolization using low-profile visualized intraluminal support junior (lvis jr) for intracranial bifurcation aneurysms; doi.Org/10.1016/j.Clineuro.2022.107275 medtronic received information in a literature article that patients potentially treated with an echelon 10 catheter had complications.The study retrospectively reviewed our databases to identify patients treated with y-stent-assisted coiling using lvis jr.Digital subtraction angiography, silent magnetic resonance angiography (mra), and time-of-flight mra were performed at 1 year after the procedure.Twenty-one patients (11 men, 10 women) with 22 aneurysms were included in this study.The mean age was 63.9 years.The pretreatment mrs scores were 0 for all patients except for one, who had an mrs score of 1 because of parkinsonism.The intracranial aneurysm location was the middle cerebral artery in eight cases, the anterior communicating artery (anterior cerebral artery a1-a2 junction) in seven cases, and the tip of the basilar artery in seven cases.The mean aneurysm size was 6.0 mm and the mean aneurysm neck length was 4.1 mm.All patients had unruptured aneurysms, with no acute phase ruptured aneurysms.Four of the 22 aneurysms were recanalized aneurysms after coil embolization.All endovascular procedures were performed under general anesthesia and systemic heparinization.A 6 f guiding sheath was introduced into the target vessel.For stent delivery, a 0.017-inch microcatheter was guided beyond the neck of the aneurysm and into the daughter branch.For coil embolization, a second microcatheter (excelsior or echelon 10) was placed into the aneurysm.The first lvis jr was deployed and implanted from the stent-delivery microcatheter.Thus, the microcatheter for coil embolization was jailed.Another stent-delivery microcatheter was guided through the first stent strut to another daughter branch.The second lvis jr was then deployed to complete the y-configuration.For coil embolization, the coils were filled as much as possible via a microcatheter.Dual antiplatelet therapy was continued for 1 year after the procedure.Following cerebral angiography at 1 year after treatment, dual antiplatelet therapy was switched to a single antiplatelet agent (aspirin).Results: all procedures were performed successfully.Seven patients (eight aneurysms) received a procedure as a bailout technique for coil protrusion.Perioperative complications were noted in two patients, with intraoperative rupture and in-stent thrombus in one case each.Although the patient with intraoperative rupture required treatment for subarachnoid hemorrhage and secondary hydrocephalus, the patient had a good recovery.In the patient with in-stent thrombosis, a small amount of thrombus was found in the stent during the procedure.Thus, we intensified his antithrombotic therapy using ozagrel sodium (thromboxane a2 synthase inhibitor), additional heparin, argatroban (direct thrombin inhibitor), and cilostazol.The patient did not develop any neurological symptoms after the procedure or during the follow-up period.In the present study, there was no permanent morbidity or death, while the mrs scores at last clinical follow-up were the same as those before the procedures in all patients.

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: 16065635
• MDR Text Key: 306317737
• Report Number: 2029214-2022-02211
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 12/28/2022

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: 12/19/2022
• Initial Date FDA Received: 12/28/2022
• 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
• Patient Age: 64 YR
• Patient Sex: Male