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); Perforation of Vessels (2135)

Event Date 04/22/2011

Event Type  Injury  

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.

Event Description

(b)(6).Repair of intracranial vessel perforation with onyx-18 using an exovascular retreating catheter technique.Journal of neurointerventional surgery.2012;4(2):121-124.Doi:10.1136/jnis.2011.004721 medtronic literature review found reported of no changes in symptoms in three out of four cases in association with onyx administration after catheter perforation of an intracranial vessel during neurovascular interventions.The purpose ofthis article was to describe how onyx administration avoids hemorrhages when catheter perforations occur during neurovascular procedures.The authors reviewed 4 cases of patients being treated for a basilar artery occlusion, stent-assisted re-treatment of a residual aneurysm, arteriovenous malformation, and an m1 occlusion using onyx after a catheter perforation of an intracranial vessel to avoid a hemorrhage.The genders were not disclosed in this article.The article does not state any technical issues during use of the echelon catheter, axium coils, and onyx.In addition, in case one, the neurological exam remained unchanged from preprocedural.At the three month follow up, the patient's modified rankin score was 2.In the second case,  a arteriogram and head ct showed patent vessels and a stable onyx cast during a two year follow up.In the third case no new neurological deficits were found post procedure.Finally, in the fourth case, the thrombolysis in myocardial infarction score was 2.The following intra- or post-procedural outcomes were noted: - intracranial vessel perforation - no changes in symptoms.

• 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: 15978854
• MDR Text Key: 305492054
• Report Number: 2029214-2022-02117
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/14/2022

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: 11/23/2022
• Initial Date FDA Received: 12/14/2022
• 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): Other; Life Threatening