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); Hemorrhage/Bleeding (1888); Thromboembolism (2654); Unspecified Nervous System Problem (4426)

Event Date 11/01/2019

Event Type  Death  

Manufacturer Narrative

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

Event Description

Lenhard pennig, lukas goertz, ulrike cornelia isabel hoyer, franziska dorn, eberhard siebert, moriz herzberg, jan borggrefe, marc schlamann, thomas liebig, and christoph kabbasch; world neurosurg.; 2021; 146:e1326-e1334; the woven endobridge (web) versus conventional coiling for treatment of patients with aneurysmal subarachnoid hemorrhage: propensity score-matched analysis of clinical and angiographic outcome data; https://doi.Org/10.1016/j.Wneu.2020.11.1.Medtronic received information in a literature article that patient's had complications regarding axium coils.  the patient's underwent conventional coiling at a single institution thereof (university hospital cologne) between january 2010 and november 2019.The antiplatelet regimen consisted of intravenous infusion of tirofiban initiated immediately before stent placement and continued for 24 hours, followed by both 4 months of oral ingestion of clopidogrel 75 mg/day and lifelong oral administration of acetylsalicylic acid 100 mg/day.Axium bare platinum coils were used. 236 patient's treated with conventional coiling with an average age of 54.4.  two patients were treated with balloon assistance. the portion of thromboembolic events was 12.2% and hemorrhagic events was 3.8%.13 events were categorized as neurologic complications.12 in the coiling group presented procedure-related infarctions. a dislocation of coils into the parent artery was present in 18 and a perforation of aneurysms in 10 patient's.In-hospital mortality rates were 17.8%.Favorable functional outcome at discharger were at 43,6%.At 6 month follow up favorable functional outcome was 55.0%.Coiled aneurysms showed complete angiographic occlusion at 82% on the final digital subtraction angiography (dsa) run of the initial treatment.

• 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: 13476726
• MDR Text Key: 285212626
• Report Number: 2029214-2022-00170
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K081465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2022
• 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
• Date Manufacturer Received: 01/28/2022
• 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; Death
• Patient Age: 54 YR