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 Chemosis (1775); Swelling/ Edema (4577)

Event Date 10/30/2015

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.If information is provided in the future, a supplemental report will be issued.

Event Description

Trehan h, sivasankar r, agrawal s, et al.Orbital apex osteodural fistula--an unusual surgical access.Indian journal of ophthalmology.2015;63(9):746-749.Doi:10.4103/0301-4738.170972 medtronic literature review found reported of periorbital dependent edema, ecchymosis, and conjunctival chemosis in association with an echelon microcatheter.The purpose of this article was to describe the treatment of an orbital apex fistula by surgically accessing the superior ophthalmic vein and performing a retrograde venous embolization.The authors reviewed a case of a patient treated for an arteriovenous fistula at the orbital apex connecting the superior ophthalmic vein and the internal carotid artery using a retrograde venous embolization.The patient was a 34 year old female and was three months post-partum.The patient presented with two months of protrusion, pain, and redness of the left eye.The left eye had prominent corkscrew episcleral vessels and had proptosed 2mm compared to the right eye.The article does not state any technical issues during use of the echelon microcatheter.In addition, the patient's intraocular pressure was 12 mmhg on the right eye and 24 mmhg in the left eye.The following intra- or post-procedural outcomes were noted: 1.Conjunctival chemosis 2.One-month post-operative proptosis and redness treated with an endovascular embolization using onyx.3.Periorbital dependent edema 4.Ecchymosis.

• 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: 16056793
• MDR Text Key: 306239683
• Report Number: 2029214-2022-02198
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 12/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2022
• 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): Other
• Patient Age: 34 YR
• Patient Sex: Female