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 Stroke/CVA (1770); Intracranial Hemorrhage (1891); Paralysis (1997); Dysphasia (2195); Confusion/ Disorientation (2553)

Event Date 06/24/2022

Event Type  Injury  

Event Description

Hou k, yu j.Case report: can ruptured aneurysms in the hypoplastic and plexiform posterior inferior cerebellar arteries be safely occluded? frontiers in neurology.2022;13:904863.Doi:10.3389/fneur.2022.904863 medtronic literature review found a report of patient complications in association with onyx and marathon catheter.The purpose of this article was to report 2 cases of ruptured aneurysms of a hypoplastic and plexiform posterior inferior cerebellar artery (pica).Endovascular occlusion of the aneurysms and parent picas was performed.A 60-year-old female suffered a sudden onset of headache and vomited 3 h before admission.The patient had a 10-year history of diabetes, but had no history of drug abuse or surgical treatment of craniocerebral diseases.On physical examination, she was drowsy.The strength of the four limbs was normal.Head ct showed subarachnoid hemorrhage (sah) concentrated at the cisterns around the brainstem and cerebellomedullary cistern.Ct angiography (cta) revealed no vascular abnormalities that might be responsible for the sah.Catheter angiography showed that the right posterior inferior cerebellar artery (pica) was hypoplastic and plexiform.Multiple slim arteries originated from the right vertebral artery (va) near the hypoplastic pica.A pseudoaneurysm was detected in the plexiform pica.Occlusion of the aneurysm and parent pica via endovascular treatment (evt) was planned under general anesthesia.A marathon microcatheter was advanced to the parent artery of the aneurysm via the guidance of a microwire to access the aneurysm.Then, the onyx l iquid embolic system was cast, successfully occluding the aneurysm and parent pica.The patient was stable postoperatively and regained consciousness 1 week later.A head ct scan performed 8 days later showed partial resolution of the sah.The patient was discharged to a local hospital for rehabilitation.A telephone follow-up revealed that they died of pulmonary infection 1 month later at the local hospital.A 53-year-old male suffered a sudden severe headache and vomited 4 h before admission.They denied having a history of chronic diseases and had no history of drug abuse or surgical treatment of craniocerebral disease.Upon admission, a physical examination was performed, and the results were unremarkable, except for nuchal rigidity.Head ct showed subarachnoid hemorrhage (sah) concentrated at the perimesencephalic cistern with involvement of the fourth ventricle.Ct angiography (cta) revealed no underlying vascular lesions.Catheter angiography revealed that the left pica was hypoplastic and plexiform.Several small arteries originated from the left vertebral artery (va) near the origin of the pica.A pseudoaneurysm was located in the hypoplastic and plexiform pica.Occlusion of the aneurysm and parent pica via evt was planned under general anesthesia.During the procedure, a marathon microcatheter was introduced into the pica via the guidance of a microwire to access the aneurysm as much as possible.Then, the aneurysm and parent pica wer e occluded with an onyx liquid embolic system.Postoperatively, he showed no consciousness or movement disturbance.Mild hoarseness, dysphagia, and left central facial paralysis were noticed.The patient was discharged 1 week later.On follow-up one and a half yea rs later, he recovered significantly, except for mild hoarseness.Mri only revealed the old brainstem infarction.The article does not state any technical issues during use of the onyx or marathon catheter.The following post-procedural outcomes were noted: -death due to pulmonary infection -partial resolution of the sah -no consciousness or movement disturbance -mild hoarseness -dysphagia -left central facial paralysis -old brainstem infarction.

Manufacturer Narrative

G2: citation: authors: hou, k., <(>&<)> yu, j.Case report: can ruptured aneurysms in the hypoplastic and plexiform posterior inferior cerebellar arteries be safely occluded?.Frontiers in neurology 13:904863 2022.Doi:10.3389/fneur.2022.904863 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.G2: the country of the event is cn 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: 17268705
• MDR Text Key: 318561595
• Report Number: 2029214-2023-01025
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K093750
• 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: 07/06/2023

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: 06/28/2023
• Initial Date FDA Received: 07/06/2023
• 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: 53 YR
• Patient Sex: Male