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 Fistula (1862); Headache (1880); Nerve Damage (1979); Perforation (2001)

Event Date 05/01/2008

Event Type  Injury  

Event Description

Luo c-b, chang f-c, teng mm-h, guo w-y, ting t-w.Transvenous embolization of cavernous sinus dural arteriovenous fistula via angiog raphic occlusive inferior petrous sinus.Journal of the chinese medical association.2015;78(9):526-532.Doi:10.1016/j.Jcma.2015.05.008 medtronic literature review found a report of patient complications in association with the echelon catheter.The purpose of this article was to evaluate the angioarchitecture of cavernous sinus dural arteriovenous fistulas (csdavfs) with angiographic occlusive trans-inferior petrous sinus (ips), and to report the experience and outcomes using transvenous coil embolization.The study consisted of 20 patients who underwent transvenous embolization via angiographic occlusive ips over a 6 year period (may 2 008 to april 2014).The patient's included seven men and 13 women, ranging from 46 years to 78 years of age (mean, 60 years).The authors retrospectively analyzed the angioarchitecture of the csdavfs, the procedural time and the angiographic as well as the clinical outcomes after embolization.The following technical issues during use of the echelon catheter were noted: -one patient suffered perforation of the ips by the catheter/guidewire with small leakage of contrast media to the subarachnoid space which led to a temporal headache.-the microcatheter was successfully navigated to the fistula site of the  cavernous sinus (cs) in 16 patients, while such navigation failed in four patients following numerous attempts the following intra- or post-procedural outcomes were noted: -successful navigation of the microcatheter into the fistula site of the csdavf was achieved in the case of 16 patients, whereas the procedure failed for four patients after many attempts.Two of these patients had undergone gamma knife radiosurgery 5 years and 6 years earlier, prior to embolization with residual fistula; they were then referred back to gamma knife radiosurgery to ascertain the feasibility of additional radiosurgery.The other two patients underwent transfacial venous or direct puncture of the cs with successful occlusion of the fistula in the same session.-complete fistula closures were documented on immediate postembolization angiograms in 15 csdavfs; one patient with residual fistula underwent transvenous onyx (covidien) embolization with total fistula occlusion.-three patients experienced temporary impairment of sixth and/or the third (n ¼ 2) cranial nerve function due to the coil mass effect in the cs; this resolved completely within 8 months.-one patient suffered perforation of the ips by the catheter/guidewire with small leakage of contrast media to the subarachnoid space which led to a temporal headache.

Manufacturer Narrative

Luo c-b, chang f-c, teng mm-h, guo w-y, ting t-w.Transvenous embolization of cavernous sinus dural arteriovenous fistula via angiog raphic occlusive inferior petrous sinus.Journal of the chinese medical association.2015;78(9):526-532.Doi:10.1016/j.Jcma.2015.05.008 a.2.This value is the average age of the patients reported in the article as specific patients could not be identified.A.3.This value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.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: 16064426
• MDR Text Key: 306316506
• Report Number: 2029214-2022-02206
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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

• Date FDA Received: 12/28/2022
• 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): Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female