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 Nerve Damage (1979)

Event Date 03/27/2023

Event Type  Injury  

Manufacturer Narrative

Continuation of d10: product id unk-nv-onyx; product id unk-nv-echelon; g2: citation: authors: ma, y., li, z., zhang, t., chen, h., chen, x., zhao, w.Efficiency of endovascular management with a combination of onyx and coils for direct and indirect carotid cavernous fistula treatment: experience of a single center.Clinical neurology and neurosurgery 228:107700.2023.Doi:(b)(6).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.If information is provided in the future, a supplemental report will be issued.

Event Description

Ma y, li z, zhang t, chen h, chen x, zhao w.Efficiency of endovascular management with a combination of onyx and coils for direct and indirect carotid cavernous fistula treatment: experience of a single center.Clinical neurology and neurosurgery.2023;228:107700.Doi:(b)(6).Medtronic literature review found a report of patient complications in association with onyx, echelon catheter and marathon catheter.The purpose of this article was to evaluate the safety and efficacy of endovascular treatment with a combination of onyx and coils for carotid cavernous fistulas (ccfs), and to characterize the factors associated with clinical and angiographic outcomes for direct and indirect ccfs.  this retrospective study included 31 patients with ccf treated with an endovascular procedure between december 2017 and march 2022.The mean age was 56.16 years, with 14 women and 17 men.Transarterial approach was used by advancing a 6 f guiding catheter or an intermediate catheter to the origin of the internal carotid artery (ica).A microcatheter (marathon/echelon) was then navigated over the microwire to reach the fistula point.The dual microcatheter technique was used in the treatment of most direct ccfs.The coiling microcatheter was navigated across the fistula to the venous side.The microcatheter for onyx delivery was navigated to a more distal location in the cavernous sinus to decrease the risk of reflux into the parent carotid artery.The coils were delivered first and avoided dense packing of the cavernous sinus (cs) with coils.A few large and long coils were packed in the cs close to the shunting point as far as possible to prevent the spillage of onyx into the sov or decrease the flow rate.After the coiling phase, onyx 18 was injected to occlude the fistula point, sinuses and drainage veins.During each onyx injection, the inflated balloon (prefer scepter c 4 × 15 mm) was kept under constant observation for balloon deflation due to contrast leak or balloon rupture, or any proximal movement of the balloon.The transarterial approach was a favorable option for embolization of direct ccfs.In contrast, the transvenous approach was the first choice of treatment for indirect ccfs.The transvenous approach via the ipsilateral or contralateral inferior petrosal sinus was used by advancing a 6 f guiding catheter to the jugular bulb, followed with microcatheters navigation to reach the cavernous sinus.After failure of the initial inferior petrosal sinus catheterization, the transvenous approach was changed to the jugular veinfacial vein-angular vein-superior ophthalmic vein approach or superior ophthalmic vein (sov) puncture approach.The procedure was terminated when angiography revealed no arteriovenous shunting or cortical venous reflux (cvr).  the article does not state any technical issues during use of the medtronic devices.The following intra- or post-procedural outcomes were noted: -partial occlusion in two patients -one case experienced procedure-related complication; transient oculomotor nerve palsy.-chemosis was significantly improved or resolved in 15 (88.2%) patients.Headache was improved in 10 (83.3%) patients.Ophthalmoplegia including double vision, drooping eyelid and eye movement restriction were improved or resolved in 10 (62.5%) patients.Visual impairment was improved in 6 (46.2%) patients.Proptosis was improved or resolved in 5 (83.3%) patients.Tinnitus was improved in 2 (40.0%) patients.One patient had no change/deterioration.

• 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: 17429121
• MDR Text Key: 320125587
• Report Number: 2029214-2023-01244
• 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: 07/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2023
• 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: 07/21/2023
• 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): Other
• Patient Age: 56 YR
• Patient Sex: Male