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); Intracranial Hemorrhage (1891); Paresis (1998)

Event Date 08/16/2021

Event Type  Death  

Event Description

J.A.Larco, m.Abbasi, y.Liu, d.Dai, g.Lanzino, l.E.Savastano, h.Cloft, d.F.Kallmes, r.Kadirvel, w.Brinjikji; american journal of neuroradiology; 2022; 43:258¿64; postprocedural thrombosis following endovascular treatment of intracranial aneurysm with flow diverters or coiling: a histologic study; doi.Org/10.3174/ajnr.A medtronic received information that patients treated with pipeline stents and axium coils had complications.The study was a retrospective histopathologic study of 4 patients who underwent mechanical thrombectomy due to acute occlusion of either implanted flow diverter devices or along coils during the treatment of intracranial aneurysm.Mechanical thrombectomy was performed by members of our neurointerventional team using 5f and 6f catheters (sofia; microvention) using the direct aspiration technique.The first patient did not use medtronic products.The second patient was a 90-year-old woman with a medical history of atrial fibrillation, non-st-elevation myocardial infarction hypertension, peripheral artery disease, gastrointestinal bleeding, and subdural hemorrhage presented to our institution with acute headache, right-sided ptosis, myosis, and intractable vomiting.Ct and cta on admission demonstrated a large subarachnoid hemorrhage secondary to bleeding from a posterior communicating artery aneurysm along with intraventricular extension.Cerebral angiography demonstrated a 6.5 x 8 mm wide-neck right posterior communicating artery aneurysm with an adjacent daughter sac along with fusiform dilation of the supraclinoid ica just distal to the ruptured aneurysm.The patient was treated with a fd (pipeline embolization device, 4.5 x 18 mm, ped; medtronic) and coil embolization (8 x 20 axium 3d coil and a 4 x12 axium helical coil; covidien) after attempted balloon-assisted coiling.The patient was immediately started on a tirofiban infusion.However, immediately after the procedure, she developed left-sided hemiparesis.A new ct scan revealed an early right-hemispheric cerebral infarction secondary to in-stent thrombosis for which she underwent mechanical thrombectomy using a 6f catheter (sofia plus) with successful recanalization.The retrieved thrombus was sent for histologic evaluation.Unfortunately, she had a large, right-hemispheric stroke and died.The third patient was a 75-year-old man with a history of gastroesophageal reflux disease and hyperlipidemia, in treatment for colon cancer, presented to our institution with headache, aphasia, dizziness, and confusion.Ct on admission demonstrated a large subarachnoid hemorrhage with ventricular extension complicated by obstructive hydrocephalus.The patient became comatose acutely, requiring intubation and the placement of an external intra-ventricular drain.Cerebral angiography demonstrated an 8.4 x 6.8 x 6.6 mm lobulated anterior communicating artery aneurysm, which was treated with coil embolization (6 x 15 mm complex axium, 5 x 10 mm helical axium, 4 x 8 mm helical axium, 3 x 6 mm helical axium coils).The final control angiogram demonstrated occlusion of the right middle cerebral artery (mca), which was recanalized in 1 pass of the thrombectomy device (5f catheter, sofia).The retrieved thrombus was sent for histologic evaluation.During the ensuing 2 days, the patient´s neurologic condition did not improve, and he died.The fourth patient was a 29-year-old woman.Noncontrast head ct demonstrated a diffuse subarachnoid hemorrhage in an aneurysmal pattern with a mild intraventricular hemorrhage.A left internal carotid artery (ica) cerebral angiogram demonstrated a 4 x 4.5 x 4.2 mm lobulated aneurysm at the origin of the posterior communicating artery, which was treated with coil embolization (2.5-mm 3d, 1.5-mm helical coils, axium).The procedure was complicated by an embolus to the left m2 trunk that was treated with aspiration thrombectomy.Two passes of a 5f catheter (sofia) were required to recanalize the artery.The retrieved thrombus was sent for histologic evaluation.The patient made a full recovery.

Manufacturer Narrative

Event related to regulatory report: 2029214-2022-02109 see for literature article.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: 15966350
• MDR Text Key: 305326073
• Report Number: 2029214-2022-02110
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2022
• 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: 11/23/2022
• 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): Death
• Patient Age: 65 YR
• Patient Sex: Female