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 Muscle Weakness (1967); Dysphasia (2195); Stenosis (2263); Thrombosis/Thrombus (4440)

Event Date 11/05/2020

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Zhang, d., gao, j., liu, y., wang, n., kang, m., sun, j., yu, y., chen, d., wang, j., <(>&<)> wen, c.(2021).Acute thromboembolic complication after stent-assisted aneurysm embolization of ruptured dissecting aneurysm in communicating internal carotid artery segment.Medicine: case reports and study protocols, 2(3).Https://doi.Org/10.1097/md9.0000000000000040.Medtronic review of the literature article found that in the procedure an echelon 10 microcatheter was used to deliver an axium 3d 6mm x 20cm and axium helix 4mm x 8cm coil to treat the 4mm x 6mm ruptured dissecting right ica posterior communicating segment aneurysm.A non-medtronic catheter was used in the middle cerebral artery (mca) to deliver a non-medtronic stent to the distal bifurcation of the right ica.The stent was released completely to partially block the neck of the aneurysm but the proximal end of the stent did not fully open.A non-medtronic balloon catheter was use to expand the proximal end of the stent.The right ica was observed for 30 minutes and remained patent and the procedure was terminated.Seven hours after the procedure, the patient became drowsy, the right limb was paralyzed and speech slurred.Urgent ct excluded rebleeding.Acute thrombosis of the non-medtronic stent was suspected but the family did not consent for emergency thrombectomy treatment and the patient was treated conservatively with iv and oral antiplatelet medications.4 days after the procedure, diffusion-weighted magnetic resonance imaging (mri) showed a high-intensity signal in the right cerebral hemisphere indicating cerebral infarction.Magnetic resonance angiography (mra) and 3d time of flight showed severe stenosis of the right mca, collateral circulation from the anterior communicating artery (aca); the aneurysm and the occlusion of the right ica were no longer seen but the stenosis of the right mca was not resolved.The patient was to continue on life-long antiplatelet medications to prevent vascular occlusion of the mca.At discharge, the patient had a moderate dysfunction with modified rankin scale (mrs) of 3 with slow gait, bilateral arm weakness, and speech lacking clarity but understandable.At 7 month follow-up, mra showed on-going stenosis if the right mca; mrs was 1 with patient's only ongoing complaint being slow gait.The physicians concluded that most likely the thrombus formation was due to the non-medtronic stent being released while not fully open and possibly the endothelium of the dissecting aneurysm contributing.Additionally, the cause of post-procedural stenosis/thrombus were suspected to be due to blood disturbance of the contralateral blood supply from the aca and possibly that the non-medtronic stent was too long in the right mca.However it was also noted that though stent placement has a risk for thromboembolic complications, postoperative thrombus formation following coiling is also possible without using stents, especially in cases of sah.

• 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: 13416483
• MDR Text Key: 289314976
• Report Number: 2029214-2022-00130
• 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: Physician
• Type of Report: Initial
• Report Date: 02/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2022
• 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: 01/26/2022
• 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; Disability
• Patient Age: 48 YR
• Patient Sex: Female