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 Problem Obstruction/Occlusion (2422)

Event Date 10/31/2022

Event Type  Injury  

Event Description

Wang, z., peng, z., chen, l., li, w., <(>&<)> wang, y.(2023).Mechanical compression management of the right middle cerebral artery inferior trunk using a stent during coil embolization of middle cerebral artery aneurysms: a case report and literature review.Journal of interventional medicine, 6(3), 126¿129.Https://doi.Org/10.1016/j.Jimed.2022.10.004.Medtronic review of the literature article found a case review of a 49-year-old male patient who underwent coil embolization of 2 in tracranial aneurysms.A review of prior literature was also completed.It was reported that the patient presented to the emergency department (ed) with severe headache and nausea x 5 hours.Computed tomography (ct) showed subarachnoid hemorrhage (sah).Diagnostic digital subtraction angiography (dsa) showed bilateral middle cerebral artery (mca) aneurysms.The right aneurysm was a ruptured 3.32 x 4.35mm mca bifurcation aneurysm with a small daughter sac on the aneurysm dome.The left was an unruptured saccular mca bifurcation aneurysm which measured 2.32 x 3.71mm.Coil embolization was performed to treat both aneurysms.For the right, ruptured, mca aneurysm, a 6f navien intracranial support catheter was navigated in the right internal carotid artery (ica) and a non-medtronic micro catheter was placed inside the aneurysm.A medtronic three-dimensional (3d) 4mm x 8cm neurovascular (nv) coil was packed into the aneurysm followed by 2 types of medtronic nv helical coils.Dsa revealed the aneurysm was still not completely occluded and the right mca remained patent.Repeat angiography after detachment of the third helical coil seemed to indicate the right mca was occluded due to compaction by the completely occluded aneurysm.A rebar-18 microcatheter was then advanced to the inferior trunk of the right mca and tirofiban was injection; it was confirmed the right mca remained patient.A 4 x 20 solitaire ab (sab) stent was then deployed in the inferior truck of the right mca to compress the aneurysm.A 3 minute bolus of intravenous tirofiban was administered to prevent acute thrombus.The left mca aneurysm coil embolization was then completed with no issue; the aneurysm was completely occluded and the parent artery and branches were patent.Post-operatively, the patient's headache was endurable.Symptoms gradually resolved and seven days later, ct scan showed the sah had been absorbed.The patient was discharged with no neurological dysfunction present.

Manufacturer Narrative

A separate report will be submitted for the navien intracranial catheter used in the procedure to treat the rupture r mca aneurysm.B3.Date article was accepted for publication is used for reported event date.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: 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: 17764263
• MDR Text Key: 323600438
• Report Number: 2029214-2023-01741
• 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: 09/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2023
• 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: 09/08/2023
• 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; Other
• Patient Age: 49 YR
• Patient Sex: Male