MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 MARATHON; CATHETER, CONTINUOUS FLUSH

Model Number UNK-NV-MARATHON

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/01/2021

Event Type  Injury  

Event Description

Yabuzaki h, terada t, tsumoto t, et al.Transarterial embolization in dural arteriovenous fistulas under sinus balloon protection using the shouryu supercompliant balloon.Interdisciplinary neurosurgery: advanced techniques and case management.2022;27.Doi:10.1016/j.Inat.2021.101415.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 the efficacy of the supercompliant shouryu balloon catheter for intrasinus balloon protection while preserving the normal venous outlet.  eighteen patients with dural arteriovenous fistulas who were treated with transarterial embolization under intrasinus balloon protection between april 2011 and july 2020 were included.Nine men and nine women were treated, and their average age was 61.1 years.Each patient received 5000 iu of heparin after sheath puncture.A 7-fr or 8-fr guiding catheter was navigated into the common carotid or external carotid artery via the transfemoral route, and selective angiography was performed using a 4-fr catheter.After the target vessel was decided on using selective angiography, a microcatheter was navigated into the target artery through the intermediate catheter, as close as possible to the shunt point, and advanced to the wedged position.A defrictor nano catheter (medico¿s (b)(6) japan) or marathon (medtronic) was usually used, but when the target feeder was wide and difficult to wedge using these catheters, they used a double-lumen balloon catheter, scepterc (microvention, tustin, ca, usa), for the onyx injection.On the venous side, a 6-fr introducer sheath was cannulated transfemorally or transjugularly.A 6-fr guiding catheter was then navigated into the dural sinus.The balloon catheter was subsequently navigated to the position where all shunts were open into the sinus.A 7-fr sheath and a 7-fr guiding catheter were used when two balloon catheters were needed.The tip of the guiding catheter was positioned adjacent to the proximal portion of the balloon to prevent migration of the balloon during inflation.The balloon was also pulled slightly to avoid migration.The balloon was then carefully inflated to occlude all shunts without obliterating the normal venous drainage r oute, such as the vein of labbe.If the normal drainage route was occluded with shunt points, the balloon was deflated after several minutes of occlusion.Onyx was injected intermittently during this period.When the targeted sinus could not be occluded by a single balloon, two balloon catheters were used in a parallel fashion.When occlusion of the feeders was observed, the onyx injection was completed and the balloon on the venous side was deflated.Angiography was then performed, and if residual shunt flow was observed, an additional onyx injection was given from the residual feeding artery.The following technical issues were noted: -the microcatheter tip was detached at a length of 1 in.During catheter retrieval after onyx injection, and the tip of the microcatheter was buried in the onyx cast in 1 patient.No neurological sequelae related to the complication.The following intra- or post-procedural outcomes were noted: -complete (n= 9) or near-complete (n = 4) occlusion was achieved in 72.2% of the patients.Partial occlusion was observed in five cases, and additional treatment was needed in only one case -pulsatile tinnitus disappeared in nine patients, but additional treatment was necessary for three patients because of residual tinnitus after endovascular surgery.-the symptoms of a patient with visual disturbance were resolved after the first treatment session, but the patient did not completely recover.The symptoms were not aggravated after the treatment -periprocedural complications were observed in 2 patients.Middle meningeal artery dissection due to catheter insertion was observed in a single patient.The microcatheter tip was detached at a length of 1 in.During catheter retrieval after onyx injection, and the tip of the microcatheter was buried in the onyx cast in 1 patient.No neurological sequelae related to these complications were observed related to these complications.

Manufacturer Narrative

Concomitant medical products: product id unk-nv-onyx.Product id unk-nv-marathon.Product id unk-nv-onyx.G2: citation: authors: yabuzaki, h., terada, t., tsumoto, t., matsuda, y., tanaka, y., nakayama, s., nishiyama, a., tetsuo, y.Transarterial embolization in dural arteriovenous fistulas under sinus balloon protection using the shouryu supercompliant balloon.Interdisciplinary neurosurgery: advanced techniques and case 2022.Doi:10.1016/j.Inat.2021.101415 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.

Manufacturer Narrative

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

Additional information received reported that the catheter tip remained: it is unknown which mc was used, however, it is not certain that there is a possibility of marathon; the tip was caught in the onyx18's cast and broke, but it was buried in that cast, so it was not considered a major adverse event.

• 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: 17649879
• MDR Text Key: 322267510
• Report Number: 2029214-2023-01523
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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: 09/22/2023
• 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
• Patient Age: 61 YR