MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 MARATHON; CATHETER, CONTINUOUS FLUSH

Model Number UNK-NV-MARATHON

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Convulsion/Seizure (4406); Unspecified Nervous System Problem (4426); Insufficient Information (4580)

Event Date 11/12/2022

Event Type  Injury  

Event Description

Quan k, liu y, wang y, et al.Treatment of high-grade brain arteriovenous malformations using a hybrid operating room: a prospective single-arm study.Clinical neurology and neurosurgery.2023;224.Doi:10.1016/j.Clineuro.2022.107517 medtronic literature review found a report of patient complications in association with onyx liquid embolic, echelon microcatheters, and marathon catheters.The purpose of this article was to examine outcomes of one-stop hybrid brain arteriovenous malformations (bavms) treatment in patients with high-grade lesions.Forty-one high-grade bavm patients underwent one-stop hybrid treatment in a hybrid operating room (hor).The one-stop hybrid procedure included combined microsurgery, intraoperative angiography, and endovascular embolization.Sixty-six propensity score-matched patients comprised the historical control group.Twenty-four patients in the hor group and 33 patients in the control group underwent preoperative endovascular treatment.Endovascular embolization was performed with several microcatheters, such as the marathon and echelon 10, and were used to selectively embolize the feeding artery with the onyx liquid embolic agent.The 44 patients in the hor group contained 26 males and 18 females, and the median age was 34.52 years.The 66 patients in the control group contained 42 males and 24 females, and the median age was 30.23 years.  the article does not state any technical issues during use of the onyx, echelon, or marathon devices.The following intra- or post-procedural outcomes were noted:   the rate of significant early surgical complications (hemorrhage, transient neurologic deficit, or infection) in the hor and control groups was 9.1 % (4 pateints) and 7.6 % (5 patients), respectively.  at last follow-up, the poor outcome rate (mrs score 2) was 15.9 % (7 patients) in the hor group and 30.3 % (20 patients) in the control group.  two patients in the hor group and five in the control group experienced new-onset epilepsy following avm resection.Engel class i seizure outcome was achieved at last follow-up in 8 of 16 patients (50 %) in the hor group and 8 of 23 patients (34.8 %) in the control group.  in four patients of the hor group, intraoperative dsa after embolization detected a residual nidus that was immediately treated with complete resection.  the rate of complete bavm obliteration at the 12-month follow-up was 100 % in the hor group and 86.4 % in the control group.

Manufacturer Narrative

Concomitant medical products: product id unk-nv-onyx; product id unk-nv-marathon; product id unk-nv-echelon; product id unk-nv-onyx; product id unk-nv-echelon; g2: citation: authors: quan, k., liu, y., wang, y., tian, y., xu, b., li, p., liu, p., shi, y., hu, l., xu, g., luo, j., song, j., (&) zhu, w.Treatment of high-grade brain arteriovenous malformations using a hybrid operating room: a prospective single-arm study.Clinical neurology and neurosurgery 224 2023.Doi:10.1016/j.Clineuro.2022.107517 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.See manufacturer report # 2029214-2023-01079, 2029214-2023-01080, 2029214-2023-01081, and 2029214-2023-01082.For other reports 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.

• Brand Name: MARATHON
• 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: 17300575
• MDR Text Key: 318926530
• Report Number: 2029214-2023-01083
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 07/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK-NV-MARATHON
• Device Catalogue Number: UNK-NV-MARATHON
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/28/2023
• 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): Required Intervention; Disability
• Patient Sex: Male