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

Model Number NOT REPORTED

Device Problem Unintended Movement (3026)

Patient Problem Neurological Deficit/Dysfunction (1982)

Event Type  Injury  

Manufacturer Narrative

Citation: high-flow extracranial-to-intracranial bypass for treatment of thrombotic parent vessel occlusion after stent-assisted aneurysm coiling as a potential rescue therapy.Lei yi1, wenyuan zhao1 et.Al (world neurosurgery (2019) 127:326-329) the devices will not be returned as it was remains in the patient; therefore, no definitive conclusion can be drawn regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report through literature review that a coil was protruded into the parent vessel that required a stent to be placed.8 days following the intervention, the patient was reported to a decrease in neurological function.A patient had a small unruptured aneurysm arising from the internal carotid artery (ica) at the level of the posterior communicating artery.It was reported that a non-medtronic microcatheter was navigated into the distal ica for stent implantation whereas a medtronic microcatheter was placed into the aneurysm sac.A detachable coil axium coil was placed to form a basket within the aneurysm; however, protrusion into the parent artery occurred despite several attempts at repositioning.Then a self-expanding non-medtronic stent was semi-deployed across the neck.With the help of the semidetached stent, the coil was successful to make a basket.Two additional non-medtronic coils were detached into the aneurysm sac.The control angiography demonstrated complete embolization of the aneurysm and good patency of the ica.The stent was then fully opened and checked for complete apposition against the wall of the ica using 3d vasoct.Post the intervention, the patient was neurologically intact and cerebral computed tomography (ct) did not reveal acute ischemic or hemorrhagic complications.The patient continued to receive daily doses of 100 mg of aspirin and 75 mg of clopidogrel.Eight days later, the patient suddenly developed symptoms of decreased level of consciousness, aphasia, and right hemiparesis.An emergent cerebral ct scan did not reveal any signs of intracerebral infarction or hemorrhage.Urgent dsa revealed acute thrombus formation within the stent and delayed opacification of the left middle thrombus and better filling in the left mca.Intravenous infusion of 4 ml/h tirofiban was continued for the next 4 days.Despite this prolonged aggressive antiaggregation, repeated angiography revealed residual thrombus but good flow in the left aca and mca.The strength of the patient¿s arm gradually recovered.It was planned to stop tirofiban and overlap back to aspirin and clopidogrel.The patient underwent magnetic resonance angiography (mra) 30 minutes after discontinuation of tirofiban while being loaded with dual antiaggregation.During the mra examination, the patient experienced symptoms of aphasia, decreased level of consciousness, and right hemiparesis.Th ree-dimensional mra showed an area of signal loss of the parent artery.It was difficult to evaluate the parent artery lumen and aneurysm neck because of the metal artifacts from the stent.

• 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: katcha taylor ; 9775 toledo way; irvine, CA 92618 ; 7635263305
• MDR Report Key: 8741388
• MDR Text Key: 149472462
• Report Number: 2029214-2019-00628
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K081465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NOT REPORTED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/05/2019
• Was Device Evaluated by Manufacturer?: No
• 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: 54 YR