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 Perforation of Vessels (2135); Unspecified Nervous System Problem (4426)

Event Date 07/16/2020

Event Type  Injury  

Event Description

Lv x, liang s.Update onyx embolization for plexiform arteriovenous malformation: ante-grade drifting technique.The neuroradiology journal.2020;33(5):386-392.Doi:10.1177/1971400920940207 medtronic literature review found a report of patient complications in association with onyx and the marathon microcatheter.The purpose of this article was to report safety and efficacy of an updated ante-grade drifting onyx injection for plexiform arteriovenous malformation (avm) embolization.Between january 2016 and december 2018, 180 feeders were catheterized and embolized with ante-grade drifting onyx injection during 116 treatment sessions in 101 patients.There were 59 male patients and 42 female patients, with ages ranging from 4 to 64 years, with an average of 26 years.Embolization was performed under general anesthesia.A 5 f sheath was placed into the femoral artery, and a 5 f guiding catheter (envoy; codman <(>&<)> shurtleff, inc.) was inserted through the sheath.The guiding catheter was continuously flushed with heparinized saline.Onyx18 (medtronicev3) was used as the embolic agent, which was delivered through a marathon microcatheter (medtronic-ev3) and navigated to the feeding arteries by a chikai-10 microguidewire (asahi intec co.Ltd) through the guiding catheter in the internal carotid or vertebral arteries.The microcatheter tip was advanced distally to select the proper feeding or contributing arteries of the avm.A coexisting aneurysm and high-flow fistula were embolized as a priority.In the ante-grade drifting onyx injection technique, onyx is injected directly without proximal plug formation.The injection speed is proportional to the size of the nidus.Onyx penetrates into the nidus and fills the compartment of the nidus backwards to the microcatheter tip.Once it reaches a safe point, the injection is stopped, and the microcatheter is retrieved.The article does not state any technical issues during use of the medtronic devices the following intra- or post-procedural outcomes were noted: -two arterial perforations occurred without causing neurological deficits.-incomplete avm obliteration in 49/101 -clinical outcomes were mrs 0¿1 in 88 patients, mrs 2 in 10 patients and mrs 3 in three patients.

Manufacturer Narrative

Continuation of d10: product id unk-nv-onyx (); product type: ; implant date ; explant date g2: citation: authors: lv, x., & liang, s.Update onyx embolization for plexiform arteriovenous malformation: ante-grade drif ting technique.The neuroradiology journal 33(5):386-392 2020.Doi:10.1177/1971400920940207.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: 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: 17452212
• MDR Text Key: 320323691
• Report Number: 2029214-2023-01280
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K202318
• 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: 08/03/2023

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-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: 07/18/2023
• Initial Date FDA Received: 08/03/2023
• 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: 26 YR
• Patient Sex: Male