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

Model Number UNK-NV-MARATHON

Device Problem Break (1069)

Patient Problem Perforation (2001)

Event Date 10/04/2021

Event Type  malfunction  

Event Description

Rodriguez-calienes a, bustamante-paytan d, camacho-caballero k, mayoria-vargas a, rodríguez-varela r, saal-zapata g.Single-center e experience with endovascular treatment of cerebral arteriovenous malformations with intent to cure in pediatric patients.Child¿s nervous system.2022;38(2):343-351.Doi:10.1007/s00381-021-05376-5.Medtronic literature review found a report of patient complications in association with onyx liquid embolic and a marathon catheter.The purpose of this article was to report the incidence of technical complications and immediate complete angiographic occlusion, identify associated factors with failure of complete occlusion and identify predictors of technical complications in a single-center experience of pediatric arteriovenous malformations (avm) treated with endovascular treatment with intent to cure.Sixty-nine patients underwent a total of 120 embolizations.Forty-six were females (66.7%) and the mean age was 12.6 years.Forty-four (63.8%) had 1 embolization treatment, 12 (17.4%) had 2 treatments, 5 (7.3%) 3 treatments, and 8 (11.7%) underwent more than 3 treatments.The most frequent embolic agent used was squid (20 cases; 30%) followed by onyx (16 patients; 23.2%), a combination of n-butyl cyanoacrylate (nbca) and onyx/squid (15 patients; 21.7%), nbca (12 patients; 17.4%), and phil (6 patients; 8.7%).The type of microcatheter used was determined according to the embolic agent used, and included magic, marathon, headway duo, and sonic catheters.There was a total of 18 technical complications (26% of patients, 15% of procedures) in this study.Fourteen patients (20.2%) presented one complication, and two patients (2.8%) showed 2 complications.There were 13 microperforations and 5 microcatheter fractures.

Manufacturer Narrative

Continuation of d10: product id unk-nv-onyx (lot: unknown).G2: citation: authors: rodriguez-calienes, a., bustamante-paytan, d., camacho-caballero, k., mayoria-vargas, a., rodríguez-varela, r., saal-zapata, g.Single-center experience with endovascular treatment of cerebral arteriovenous malformations with intent to cure in pediatric patients.Child¿s nervous system 38(2):343-351 2022.Doi:10.1007/s00381-021-05376-5.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: 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: 17667221
• MDR Text Key: 322503565
• Report Number: 2029214-2023-01556
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: PE
• 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: 08/31/2023

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?: Yes
• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/31/2023
• 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
• Treatment: SEE H10...
• Patient Age: 12 YR
• Patient Sex: Female