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 Intracranial Hemorrhage (1891); Heart Failure/Congestive Heart Failure (4446)

Event Date 12/09/2021

Event Type  Death  

Manufacturer Narrative

Continuation of d10: product id unk-nv-onyx (lot: unknown); product id unk-nv-marathon (lot: unknown); product id unk-nv-echelon (lot: unknown); product id unk-nv-onyx (); product id unk-nv-echelon (); product id unk-nv-onyx (); product id unk-nv-marathon (); product id unk-nv-echelon (); g2: citation: authors: liu, d., zhang, s., ma, x., li, z., ge, h., wang, y., & lv, m.The influence of hemorrhage presentation on clinical outcomes of curative embolisation in 125 cerebellar arteriovenous malformations.British journal of neurosurgery december 2021:1-7 2021.Doi:10.1080/02688697.2021.2013436.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 # 2029214-2023-01377 for another report 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.

Event Description

Liu d, zhang s, ma x, et al.The influence of hemorrhage presentation on clinical outcomes of curative embolisation in 125 cerebellar arteriovenous malformations.British journal of neurosurgery.December 2021:1-7.Doi:10.1080/02688697.2021.2013436.Medtronic literature review found a report of patient complications in association with onyx liquid embolic, marathon microcatheter, and echelon 10 microcatheter.The purpose of this article was to report the results of patients with cerebellar arteriovenous malformations (cavms) treated with endovascular embolization, and explore the risk factor of hemorrhage within cavms.Only cavms patients who underwent endovascular treatment as the first treatment with at least 2 years of follow-up were included in this study.There were 125 cavm patients included that received endovascular embolization via onyx or glubran 2.A total of 68 patients were embolized with onyx 18, while 57 were embolized using glubran 2.Marathon microcatheters or echelon 10 microcatheters were used via a double microcatheter injection technique.Of the 125 cavms patients, 67 were female (53.6%) and 58 were male (46.4%).The mean patient age was 43 years.In the 125 patients, 82 aneurysms were identified, and 69 aneurysms ruptured.All aneurysms were embolized with a coil or liquid embolic material (onyx 18 or glubran 2 glue).The following intra- or post-procedural outcomes were noted:  four patients died.One patient with an sm grade iv and two patients with an sm grade v had avms with incomplete embolization and died due to intracranial hemorrhage, and one patient (0.8%) died due to cardiovascular events. six patients experienced operative hemorrhagic complications.Six patients presented with headache (4.8%) due to aneurysms ruptured before and during the operation, and they had a good recovery at discharge (mrs less than or equal to 2).Three patients had intracranial hemorrhage due to the incomplete embolization of cavms.Three patients (2.4%) who were embolized by glubran 2 had intracranial hemorrhage during the withdrawal of the microcatheter.The damaged artery was embolized immediately, and the patients had a favorable recovery at discharge (mrs = 2).Arterial perforation due to the microcatheter operation occurred in 4 total patients (3.2%).After a 1-year follow-up, there were no clinical consequences for these patients. ten patients experienced operative ischemic complications: vasospasm in six patients and misembolization arteries in four patients with no neurologic impairment after 1 year. there were 12 other operational complications.Nine patients (7.2%) were said to have surgical technique complications. a total of 30 patients (24.0%) had non-procedure related complications such as headache (12 patients), dizziness (six patients), and transmit neurological deficits.Fourteen patients experienced nonoperative ataxia. nine patients experienced nonoperative hydrocephalus.Of the twelve total patients (9.6%) that presented or developed hydrocephalus, three patients developed hydrocephalus due to hemorrhagic complications after embolization and nine patients presented hydrocephalus due to avms hemorrhage before the operation.External ventricular drainage was performed in five patients to alleviate intracranial hypertension.Another seven patients with radiologically mild hydrocephalus were untreated.Overall, five patients required permanent ventriculoperitoneal shunting.Two patients had gradually developed hydrocephalus after discharge. two patients (0.8%) were embolized by glubran 2 and had microcatheter breaks when it retreated and remained intravascular. thirty-six patients underwent endovascular embolization (20 patients) or gamma knife radiotherapy (16 patients) for residual avms. twelve patients (9.6%) had poor outcomes (mrs 3-4).Six patients had a worsened mrs evaluation, four patients of whom had good outcomes (three patients, mrs 1 and one patient, mrs 2) with 1 year follow-up time.

• 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: 17543309
• MDR Text Key: 321098327
• Report Number: 2029214-2023-01378
• 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: 08/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2023
• 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: 08/08/2023
• 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): Death
• Patient Age: 43 YR
• Patient Sex: Female