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 Problem Pain (1994)

Event Date 12/16/2010

Event Type  Injury  

Manufacturer Narrative

Continuation of d10: product id: unk-nv-onyx (); g2: citation: authors: patel, d.V., rangaswamy, r., lesley, w.S., hester, j.L., mcdonald, d.K., tsai, j.H.Transvenous embosurgery of a left sigmoid sinus dural arteriovenous fistula via a retrograde approach from the superior ophthalmic vein, cavernous and inferior petrosal sinuses.Journal of neurointerventional surgery 3(3):229-232 2011.Doi:10.1136/jnis.2010.003848.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#: 2029214-2023-01414 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.

Event Description

Patel dv, rangaswamy r, lesley ws, hester jl, mcdonald dk, tsai jh.Transvenous embosurgery of a left sigmoid sinus dural arteriovenous fistula via a retrograde approach from the superior ophthalmic vein, cavernous and inferior petrosal sinuses.Journal of neurointerventional surgery.2011;3(3):229-232.Doi:10.1136/jnis.2010.003848.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 first embosurgery of a sigmoid sinus dural arteriovenous fistula (davf) via a superior ophthalmic vein (sov) approach.The article does not state any technical issues during use of the onyx or marathon.The following intra- or post-procedural outcomes were noted: using a marathon catheter, the branches of the left external carotid artery, which supplied the davf malformation, were embolized using onyx.Due to the significant tortuosity and small caliber of the external carotid branches, the nidus was not penetrable.Angiography however demonstrated marked reduction of flow traversing through the inferior petrosal sinus and sov.On the first postoperative day, the patient developed significant left eye pain, which was suspicious for acute thrombosis of the left sov.Mri demonstrated a patent but persistently dilated left sov.Subsequently, under general anesthesia, direct access through the left ophthalmic vein was performed.Using a superior orbital cut-down, the sov was identified with roadmap fluoroscopy.Again under fluoroscopic guidance, the left ophthalmic vein was then punctured and a microsheath was introduced.Through the sheath, a microcatheter over wire technique was successful in crossing the cavernous and inferior petrosal sinuses to reach the left sigmoid sinus and jugular bulb junction.The sigmoid sinus davf was embolized using onyx and coils.Postoperative angiogram no longer demonstrated flow through the arteri ovenous malformation and the patient¿s symptoms subsided immediately afterwards.A 3 month follow-up angiogram demonstrated durable obliteration of the davf.Physical examination at that time revealed nearly complete resolution of the patient¿s proptosis and diplopia.

• 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: 17561475
• MDR Text Key: 321312311
• Report Number: 2029214-2023-01415
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/16/2023

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: 07/24/2023
• Initial Date FDA Received: 08/16/2023
• 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 Outcome(s): Required Intervention