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

Model Number UNK-NV-MARKSMAN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Intracranial Hemorrhage (1891); Perforation (2001); Obstruction/Occlusion (2422)

Event Date 06/05/2023

Event Type  Injury  

Event Description

Aoto shibata, taro yanagawa, shin sugasawa, shunsuke ikeda, toshiki ikeda; radiology case reports; 2023; 18: 3206-3211; multiple large vessel occlusions resulting in vessel perforation in single pass of mechanical thrombectomy with stent retriever; doi.Org/10.1016 /j.Radcr.2023.06.024 medtronic received information that a patient treated with a marksman catheter and solitaire stent had complications.The purpose of the article was to report a case of mechanical thrombectomy (mt) with a stent retriever for multiple large vessel occlusion in the internal carotid artery and middle cerebral artery m1 distal, which resulted in vessel perforation in a single pass.A 79-year-old woman underwent mt for internal carotid artery occlusion, and multiple large vessel occlusion was observed on digital subtraction angiography. mt was performed under local anesthesia.A 9-fr balloon guide catheter (bgc) was placed in the right ica using the transfemoral artery approach. right ica angiography (icag) confirmed ica terminal occlusion.A stent retriever (sr) monotherapy was used for clot retrieval under roadmap guidance.Further, the marksman microcatheter was advanced to the m2 segment of the middle cerebral artery.Microangiography revealed thrombus translucency in the m1 distal, which differed from that of the ica occlusive lesion.The lesions were believed to be multiple large vessel occlusion (mlvo).A longer and larger stent (6.0 × 40 mm, solitaire, medtronic) was selected and used to simultaneously retrieve both lesions.The proximal marker of the device was aligned with the ica thrombus, and the distal marker was overlapped at the m2 origin to deploy the sr from the m2 segment into the supraclinoid portion of the ica.Icag immediately after deployment confirmed ica restoration.After 120 seconds, the sr was slowly retrieved at a constant rate under bgc inflation and manual suction.The red embolic material was trapped near the proximal marker of the sr.After the ica was released, the blood flow was restored on icag.However, the m1 distal was not restored.Due to new findings of extravasation from the m1 distal occlusion, the bgc was inflated again, and the patient¿s blood pressure was controlled below 100 mm hg after heparin reversal with 5 mg protamine.The extravasation had disappeared after icag was performed again.After 5 minutes,hemostasis was maintained on icag, and the treatment was interrupted.Final angiography confirmed the absence of flow (thrombolysis in cerebral ischemia: grade 0).Postoperative computed tomography (ct) scan showed subarachnoid hemorrhage.However, the patient continuously received antihypertensive therapy and osmotherapy.After 4 hours, follow-up ct scan revealed an expanded subarachnoid hemorrhage.Hence, emergency craniotomy was performed as anisocoria was also noted simultaneously.Craniotomy procedure: right frontotemporal craniotomy was performed.The right m1 segment was identified using the subfrontal approach, and the sylvian fissure was opened.A linear perforation with a diameter of 1 mm was observed in the m2 superior trunk immediately after the bifurcation, which was the site of sr deployment.The dissecting of vessel wall or pseudoaneurysm was not observed.To completely isolate the perforation, trapping was performed at 5 points including the perforating branches.Outcome: postoperative ct scan revealed good decompression after hematoma removal, and there was no rebleeding.The patient continuously underwent rehabilitation and recovered.Then, she was transferred to a rehabilitation hospital, with a modified rankin scale score of 5.

Manufacturer Narrative

See attachments for literature.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: MARKSMAN
• 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: 18361271
• MDR Text Key: 330935141
• Report Number: 2029214-2023-02415
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK-NV-MARKSMAN
• Device Catalogue Number: UNK-NV-MARKSMAN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2023
• 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): Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female