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 Stroke/CVA (1770); Fatigue (1849); Paralysis (1997); Dysphasia (2195); Stenosis (2263); Quadriplegia (2449); Respiratory Failure (2484); Vascular Dissection (3160); Thrombosis/Thrombus (4440)

Event Date 03/04/2021

Event Type  Injury  

Manufacturer Narrative

Gao f, han j, guo x, sun x, ma n, miao z.Endovascular recanalization for non-acute basilar artery occlusions with progressive or recurrent ischemic symptoms: a multicenter clinical experience.Journal of neurointerventional surgery.2022;14(2):133-137.Doi:10.113 6/neurintsurg-2020-017213.See manufacturer report # 2029214-2022-02172.For another report from this article.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

Gao f, han j, guo x, sun x, ma n, miao z.Endovascular recanalization for non-acute basilar artery occlusions with progressive or recurrent ischemic symptoms: a multicenter clinical experience.Journal of neurointerventional surgery.2022;14(2):133-137.Doi:10.113 6/neurintsurg-2020-017213.Medtronic literature review found a report of patient complications in association with an echelon 10 microcatheter.The purpose of this article was to report a multicenter clinical experience of endovascular recanalization for symptomatic non-acute basilar artery occlusion (bao) and propose an angiographic grouping to determine which patient subgroup most benefits from this treatment.Forty-two patients with non-acute bao with progressive or recurrent vertebrobasilar ischemic symptoms who underwent endovascular recanalization were included.Thirty-three of the subjects were male, with a mean age of 58.76 years.An echelon 10 microcatheter were used in some of the procedures.The article does not state any technical issues during use of the echelon microcatheter.The following intra- or post-procedural outcomes were noted: - there were 3 other cases of periprocedural perforator infarction.Postprocedural ct scans revealed newly emerged infarcts in the b rainstem, and transcranial doppler indicated good patency of the ba.Two patients had minor ischemic stroke (nihss score 3 or 4), which was relieved before discharge (mrs 1 and 2).The other patient experienced major ischemic stroke.One patient suffered from a medullary lesion following the recanalization and experienced dysarthria, left hemiplegia, respiratory failure, and somnolence.The patient recovered gradually after ventilation and medical treatment and achieved a mrs score of 3 before discharge.- there was 1 case of periprocedural dissection.The patient underwent vascular dissection during the recanalization, and the operation terminated unfavorably.The patient developed locked-in syndrome with worsening postprocedural symptoms, and cerebral mri revealed newly emerged infarcts in the brainstem.- there was 1 case of periprocedural thrombosis.The patient developed acute stent thrombosis during the operation and was treated with recombinant tissue plasminogen activator and intra-arterial tirofiban followed by recanalization, leading to a new postprocedural infarction (nihss score 3).- there were 6 total cases of ischemic stroke within 30 days of the procedure.- two patients experienced ischemic stroke in the brainstem and ipsilateral cerebellum 3 or 6 months after recanalization.Cta demon strated the occurrence of in-stent restenosis, and the symptoms were alleviated by rehabilitation and drug treatment (mrs scores 1 and 2).There were 4 total cases of restenosis following the procedure.

• 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: 16040506
• MDR Text Key: 306069891
• Report Number: 2029214-2022-02174
• 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
• Report Date: 12/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2022
• 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: 12/19/2022
• 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): Life Threatening; Required Intervention; Disability
• Patient Age: 58 YR
• Patient Sex: Male