MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 AXIUM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number UNK-NV-AXIUM

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

Patient Problems Stroke/CVA (1770); Hematoma (1884); Intracranial Hemorrhage (1891); Transient Ischemic Attack (2109); Vasoconstriction (2126); Rupture (2208); Obstruction/Occlusion (2422); Unspecified Nervous System Problem (4426); Thrombosis/Thrombus (4440); Swelling/ Edema (4577)

Event Date 01/01/2006

Event Type  Injury  

Manufacturer Narrative

Zhou y, duan g, zhang x, et al.Outcome and prognostic factors of ruptured middle cerebral artery aneurysms treated via endovascular approach: a single-center 11-year experience.World neurosurgery.2020;133:e187-e196.Doi:10.1016/j.Wneu.2019.08.189.If information is provided in the future, a supplemental report will be issued.

Event Description

Zhou y, duan g, zhang x, et al.Outcome and prognostic factors of ruptured middle cerebral artery aneurysms treated via endovascular approach: a single-center 11-year experience.World neurosurgery.2020;133:e187-e196.Doi:10.1016/j.Wneu.2019.08.189   medtronic literature review found a report of patient complications in association with the solitaire stent and axium prime coil.The purpose of this article was to investigate outcomes and prognostic factors of ruptured middle cerebral artery (mca) aneurysms, treated via endovascular approach, with improving treatment materials and techniques.A total of 185 consecutive patients, admitted with acutely ruptured, saccular mca aneurysms and treated by endovascular methods between january 2006 and december 2016, were retrospectively reviewed.Their baseline characteristics, procedure-related complications, and angiographic and clinical outcomes were collected.Univariate analysis and logistic regression analysis were completed to identify any association between procedure-related complications or clinical outcomes and potential risk factors.The article does not state any technical issues during use of the solitaire stent and axium coil.The following intra- or post-procedural outcomes were noted: -procedure-related complications occurred in 28 patients, including aneurysm rebleeding in 7, hematoma expansion in 10 and ischemia in 13 (concurrent hemorrhage and ischemia in 2 patients).Sixteen of these complications resulted in either death (3/185) or permanent neurologic deficits (13/185).-among 17 hemorrhagic complications, 7 were aneurysm rebleeding, of which 6 occurred during the procedure (rupture), whereas the other was postoperative rebleeding.Six required hematoma evacuation and decompressive craniotomy to control intracranial pressure.After discharge, 1 patient died, 3 were severely disabled (mrs score 4-5), 1 was mildly disabled (mrs score 3), and 2 achieved functional independence (mrs score less than 2).Permanent disability occurred in 3, whereas others recovered well during follow-up.-hematoma expansion occurred in 10 patients.Hematoma evacuation and decompressive craniotomy were performed for all except one, who refused surgery.When discharged, 1 died, and 9 were severely disabled (mrs score 4-5).Clinical improvement was observed in all but 2 surviving patients.Clinical assessment, at last follow-up, identified severe disability in 2 patients (mrs score 4-5), mild disability in 5 patients (mrs score 3), and good recovery (mrs score less than 2) in the remaining 2 patients.-among 13 ischemic complications, 5 included side-branch occlusion, caused by coil protrusion; 3 experienced intrastent thrombosis; and 5 had thrombosis at the aneurysm neck, caused by minor coil protrusion or endothelial cell injury.Ischemic symptoms were observed in 6/13 patients (5 brain infarction and 1 tia) whereas no new neurologic deficits were identified in others after prompt treatment.At last follow-up, 3 patients were mildly disabled and 9 recovered well, but 1 died of severe pneumonia after hydrocephalus.-in addition to the procedure-related complications, hematoma evacuation and decompressive craniotomy were undertaken in the remaining 12 patients with massive intracranial hematoma, and external cerebrospinal fluid drainage was required in 1 patient, to control intracranial pressure.At the last follow-up evaluations of those 13 patients, 6 had died, 6 were dependent, and 1 was independent.Symptomatic cerebral vasospasm occurred in 10 patients, all of whom recovered well after aggressive antivasospasm treatments, which included intra-arterial administration of fasudil (rho kinase inhibitor).In addition, 1 patient died of cardiac arrest, 7 days after the procedure.Clinical evaluation (mrs) was carried out for the remaining 177 patients at discharge.Of those patients, 142 were independent with an mrs score of 0=2 at discharge, whereas the remaining 35 were dependent, because of procedure related complications, sah-related complications, or initial brain injury.Of these 35 patients, 4 achieved an mrs score of 3, 18 had an mrs score of 4, and 13 had an mrs score of 5.During follow-up, 28 of these 35 dependent patients were clinically improved and included 6 with severe disabilities (mrs score 4-5), 10 with mild disabilities (mrs score 3), and 12 with a good recovery (mrs score 0-2).Four patients died during followup, including 1 of unrelated causes and 3 because of poor general condition or sah-related complications.-final evaluations of these patients indicated that 153 patients had a good outcome (mrs score 0-2).Among 120 who underwent angiographic follow-up, 89 were completely occluded and 20/120 were recanalized.85 of 185 aneurysms  were completely occluded (raymond class i), 58 had a remnant neck (raymond class ii), and 38 had a residual sac (raymond class iii).Fourteen patients were retreated with stent-assisted coiling.

• Brand Name: AXIUM
• Type of Device: DEVICE, NEUROVASCULAR EMBOLIZATION
• 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: 16259144
• MDR Text Key: 308345175
• Report Number: 2029214-2023-00128
• Device Sequence Number: 1
• Product Code: HCG
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK-NV-AXIUM
• Device Catalogue Number: UNK-NV-AXIUM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2023
• 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; Life Threatening; Disability