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 Fever (1858); Ischemia (1942); Nausea (1970); Pain (1994)

Event Date 01/27/2023

Event Type  Injury  

Event Description

Wang m-d, tian w, zhou c-g, liu s.Safety and efficacy of the double microcatheter technique for splenic artery aneurysms: a single-center retrospective study.Vascular and endovascular surgery.2023;57(6):541-546.Doi:10.1177/15385744231154087.Medtronic literature review found a report of patient complications in association with the echelon catheter.The purpose of this article was to assess the safety and efficacy of the double microcatheter technique for the treatment of splenic artery aneurysms.From november 2013 to october 2020, 56 patients  (22 men and 34 women) with saccular splenic artery aneurysms underwent endovascular treatment with the double microcatheter technique.The mean age of the patients was 58.0 years (range: 28-84).All procedures were performed using the double microcatheter technique.All patients received local anesthesia in the right inguinal area, and access to the right common femoral artery was achieved using a 7 french (7 f) vascular sheath.Selective splenic artery dsa was performed through a 5 f c2 cobra catheter to obtain three-dimensional (3d) reconstruction images.A 7 f rdc guiding catheter was placed at the opening of the splenic artery.The first microcatheter tip was placed inside the aneurysmal sac using a 0.014-inch wire.Subsequently, the double catheter technique was performed by inserting the second microcatheter through the previously inserted guiding catheter.After positioning the two microcatheters within the aneurysmal sac, the first detachable coil (hydroframe, microinvention inc.) was partially deployed through the first microcatheter for reference.A second detachable coil was inserted through the second microcatheter.Subsequently, the two detachable coils intertwine and support each other to create a stable coil frame.The article does not state any technical issues during use of the echelon catheter the following intra- or post-procedural outcomes were noted: -clinical success at 1 month postoperatively was 96.4% (54 of 56).The clinical success rates at 6 and 12 months postoperatively were both 92.9% (52 of 56).Compared with the technical success, the additional cases in which failure occurred consisted of three patients with splenic artery aneurysms.They were diagnosed with splenic infarction through imaging examination.One patient developed a small-scale splenic infarction postoperatively.At the 6-month follow-up, the ct imaging demonstrated that the scale of splenic infarction was smaller than that at the postoperative follow-up.However, these patients did not experience any discomfort.There were no aneurysmal recurrences or necessary reintervention.-minor complications included fever, pain, and nausea and occurred in 13 patients (23.2%).Active symptomatic treatment was performed for these minor complications, which were resolved within 2-3 days.No bleeding or death was associated with aneurysmal embolization of the splenic artery during hospitalization.No embolization-related mortality or major complications were recorded.

Manufacturer Narrative

G2: citation: authors: wang, m.-d., tian, w., zhou, c.-g., & liu, s.Safety and efficacy of the double microcatheter technique for splenic artery aneurysms: a single-center retrospective study.Vascular and endovascular surgery 6 2023.Doi:10.1177/15385744231154087.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.Earliest date of publication used for date of event no unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.Without return of the product no definitive conclusion can be made regarding the clinical observations.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: 17851359
• MDR Text Key: 324686367
• Report Number: 2029214-2023-01908
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K042187
• 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: 10/02/2023

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: 09/22/2023
• Initial Date FDA Received: 10/02/2023
• 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: 58 YR
• Patient Sex: Female