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); Vasoconstriction (2126)

Event Date 11/24/2023

Event Type  Death  

Event Description

Wang, j.-w., li, c.-h., liu, j.-f., li, h., guo, h., & gao, b.-l.(2023).Endovascular treatment of multiple intracranial aneurysms.Medicine, 102(47).Https://doi.Org/10.1097/md.0000000000036340 medtronic literature review found reported of patient complications in association with pipeline device.The purpose of this article was to investigate the safety and effect of endovascular treatment of patients with multiple cerebral aneurysms.Abstract: multiple intracranial aneurysms are difficult to treat.In order to investigate the effect and safety of endovascular treatment for  multiple intracranial aneurysms, 54 consecutive patients with 116 multiple intracranial aneurysms treated with endovascular  embolization were retrospectively enrolled.Angiography was performed immediately after embolization and at each follow-up.All clinical data were analyzed.Of the 116 aneurysms, 56 (48.3%) were embolized with coiling alone, 19 (16.4%) with stent assisted coiling, 31 (26.7%) with stenting alone, and 10 (8.6%) with flow diverters plus coiling.After embolization, 31 (27.6%) aneurysms with stenting alone had no apparent change in size, and in the remaining 84 aneurysms, complete occlusion was achieved in 50 aneurysms (59.5%), near-complete occlusion in 26 (31.0%), and incomplete occlusionin 8 (9.5%).Thrombus formation at the aneurysm neck occurred in 3 patients (5.6%), coil protrusion in 2 (3.7%), and intraprocedural rupture in 1 (1.9%), resulting in a total complication rate of 11.1%.Follow-up angiography was performed in 44 (81.5%) patients 6 to 90 months (mean 49) later.Among 50 completely occluded aneurysms, 38 (76%) aneurysms remained completely occluded, and 4 (8%) aneurysms recurred.Among 26 aneurysms with initial near-complete occlusion, 12 (46.2%) aneurysms with neck remnant had progressive thrombosis to complete occlusion, 2 (7.7%) had no change compared with immediate occlusion, and 5 (19.2%) regrew.In conclusion, endovascular embolization with intracranial stenting and coiling is safe and effective and may play an increasingly important role in the management of multiple intracranial aneurysms.The following intra-procedural or post-procedural outcomes and technical issues were noted: 2 patients harboring 6 aneurysms died of subarachnoid hemorrhage (sah) and delayed vasospasm even if the ruptured aneurysm had been successfully embolized.There was thrombus formation at the aneurysm neck in 3 patients.Thrombus formation was treated with thrombolysis and continued an ticoagulation without causing branch occlusion or neurological deficit.There was intraprocedural rupture in 1 patient.Intraprocedural rupture was verified in 1 patient by contrast extravasation and co ntinued coiling led to a good result with no neurological deficit.Vasospasm secondary to subarachnoid hemorrhage (sah) occurred in 7 patients and treated with super-selective intra-arterial infusion of verapamil or papaverine.Immediately after embolization, 31 (26.7% or 31/116) aneurysms which were treated with stenting alone had no apparent change in the aneurysm dome.In the remaining 84 (72.4% or 84/116) aneurysms treated with coiling alone, stent-assisted coiling, or flow diversion plus coiling, complete occlusion was achieved in 50 aneurysms (59.5% or 50/84), near-complete occlusion (or neck remnant) in 26 (31.0% or 26/84), and incomplete occlusion (or partial occlusion) in 8 (9.5% or 8/84).Follow-up angiography was performed in 44 patients.4 (8%) aneurysms recurred with 2 recurred aneurysms being retreated with stent-assisted coiling to complete occlusion.Among 26 aneurysms with initial near-complete occlusion, 12 (46.2%) aneurysms with neck remnant experienced progressive thrombosis to complete occlusion, 2 (7.7%) had no change compared with immediate occlusion after embolization, and 5 (19.2%) regrew (with 3 retreated).Among 8 aneurysms with incomplete occlusion, 5 (62.5%) aneurysms progressed to complete occlusion, 2 (25%) remained unchanged, and 1 (12.5%) was recurrent.Among 31 aneurysms treated with stenting alone, 22 aneurysms in 15 patients with angiographic follow-up all had progressive thrombosis, leading to the aneurysm cavity decreased (14 or 63.6%) or disappeared (8 or 36.4%).In case the flow diverter was not well attached to the arterial wall, a microguide wire combined with a microcatheter was applied to ¿massage¿ the diverter, or a balloon catheter was used to expand the diverter.

Manufacturer Narrative

Citation: wang, j.-w., li, c.-h., liu, j.-f., li, h., guo, h., & gao, b.-l.(2023).Endovascular treatment of multiple intracranial aneurysms.Medicine, 102(47).Https://doi.Org/10.1097/md.0000000000036340 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.Patient age and sex are the mean of the patients in the study.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• 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: 19193436
• MDR Text Key: 341169709
• Report Number: 2029214-2024-00763
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2024
• 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: 04/09/2024
• 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): Death
• Patient Age: 56 YR
• Patient Sex: Female