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 Hematoma (1884); Intracranial Hemorrhage (1891); Blurred Vision (2137); Visual Disturbances (2140); Bronchopneumonia (2437); Vascular Dissection (3160); Convulsion/Seizure (4406); Unspecified Nervous System Problem (4426); Swelling/ Edema (4577)

Event Date 12/19/2022

Event Type  Injury  

Manufacturer Narrative

G2: citation: authors: vollherbst, d.F., boppel, t., wallocha, m., berlis, a., maurer, c.J., weber, w., fischer, s., bock, a., meckel, s., bohner, g., liebig, t., herweh, c., bendszus, m., chapot, r., <(>&<)> mo¨hlenbruch, m.A.Liquid - treatment of high-grade dural arteriovenous fistulas with squid liquid embolic agent: a prospective, observational multicenter study.Journal of neurointerventional surgery 11 2023.Doi:10.1136/jnis-2022-019859 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.Date of acceptance 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.

Event Description

Vollherbst df, boppel t, wallocha m, et al.Liquid - treatment of high-grade dural arteriovenous fistulas with squid liquid embolic agent: a prospective, observational multicenter study.Journal of neurointerventional surgery.2023;15(11):1111-1116.Doi:10.1136/j nis-2022-019859 medtronic literature review found a report of patient complications in association with the marathon and apollo catheter.The purpose of this article was to assess the safety, efficacy, and short-term outcome of the treatment of dural arteriovenous fistulas (davfs) using the new liquid embolic agent squid.In eight centers, fifty-three patients with a mean age of 60 years, most of them male (77.4%), treated between january 2017 and september 2019, were included in this study.In total, 55 treatments were performed (two patients had two treatment sessions).The two most frequently used microcatheters were the marathon (medtronic; 61.1%) and the scepter xc balloon catheter (microvention, aliso viejo, usa; 13.9%).Apollo catheter was used in 11.%.Accessory devices were used in 32.7% (21.8% balloon-assisted embolization, 5.5% balloon protection of healthy arterial blood vessels, and 5.5% coiling).The balloon-assisted embolizations were performed using the scepter xc (81.8%), scepter mini (microvention; 9.1%), or eclipse 2 l (balt; 9.1%).Of the three coiling cases, transvenous coiling was performed in two, either after partial transarterial embolization or after complete embolization for stabilization of the occlusion.In the third case, coils were used for the pressure-cooker technique.Adverse events (aes) occurred during or after 10 (18.2%) treatments, consisting of two (3.6%) intraprocedural complications (dissection and microcatheter rupture) and eight (14.6%) postprocedural complications (two cases of groin hematomas and seizures, respectively, and one case of intracerebral hemorrhage, pulmonary embolism, pneumonia, and visual disturbances, respectively).The rate of severe or life-threatening aes was 5.5% (one case of intracerebral hemorrhage, pulmonary embolism, and seizure, respectively).Of the patients who developed aes, 7/10 recovered without sequelae, while 1/10 recovered with sequelae, 1/10 did not yet recover, and 1/10 died.The patient who died had a fatal pulmonary embolism, unrelated to the procedure, 4 days after the treatment.In that patient, no specific reason for the embolism was found and no radiopaque embolic agent was detected within the pulmonal arteries in the chest ct, but the patient had multiple vascular risk factors, such as obesity, heart failure, and arterial hypertension.Procedure-related aes resulting in permanent morbidity were observed in 3.6% (one case of postinterventional hemorrhage of the davf and one case of visual disturbances (blurry vision and scotoma) due to focal edema adjacent to the fistula point).The intracerebral hemorrhage was treated with craniotomy and hematoma evacuation and the patient recovered with only mild residual symptoms and an mrs score of 0 at the latest follow-up.No specific reason for the hemorrhage could be found.The symptoms of the patient with visual disturbances partially resolved with an mrs score of 1 at the latest follow-up.After a mean clinical follow-up of 5.3 months, which was available for 43 patients, the mrs score was stable or improved in 93.0%.Of the patients with worsening mrs, only one case (1.8%; visual disturbances) was related to the procedure.The following technical issue was noted: -one case of microcatheter rupture was reported.No specific reason, such as sedimentation of the embolic agent leading to clogging of the microcatheter, was found to be responsible for this rupture.The following intra- or post-procedural outcomes were noted: - 1 dissection  - 2 cases of groin hematomas - 2 cases of seizures - 1 case of intracerebral hemorrhage - 1 case of pneumonia - 1 case of visual disturbances (blurry vision and scotoma) due to focal edema adjacent to the fistula point - 1 case of worsening mrs.

• 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: 18707697
• MDR Text Key: 335405480
• Report Number: 2029214-2024-00287
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 02/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2024
• 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: 02/08/2024
• 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): Life Threatening; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male