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 Aneurysm (1708); Thromboembolism (2654)

Event Date 07/01/2020

Event Type  Injury  

Manufacturer Narrative

Coding representative of serious adverse events reported in the article.Non-serious adverse events have been processed separately.If information is provided in the future, a supplemental report will be issued.

Event Description

Greve, t., sukopp, m., wostrack, m., burian, e., zimmer, c., friedrich, b.(2021).Initial raymond¿roy occlusion classification but not packing density defines risk for recurrence after aneurysm coiling.Clinical neuroradiology: official journal of the german, austrian, and swiss societies of neuroradiology, 31(2), 391¿399.Https://doi.Org/10.1007/s00062-020-00926-x.Medtronic review of the literature article found review of 267 cases of coil embolization to treat aneurysm to study the relationship of initial coil packing density or type of aneurysm residual perfusion as measured with the modified raymond-roy occlusion classification (mrrc).A ruptured intracranial aneurysm was treated in 157 ((b)(4)) patients (ria group), and an unruptured intracranial aneurysm was treated in 110 ((b)(4)) patients (uia group).No intra-operative device malfunctions were reported.Intraoperatively, 17 patient experience thromboembolic events - 9 patients from the ria group and 8 from the uia group.Of the 209 patients who were noted to have incomplete occlusion post-operatively (mrrc ii, iiia, or iiib), 62 underwent additional treatment procedures - 53 underwent additional coiling procedures and 9 underwent aneurysm clipping procedures.6 patients were noted to have aneurysm rupture intra-operatively but no information was reported regarding additional treatment or intervention.There was no additional treatment described in 61 of the 209 patients who were noted to have incomplete occlusion (mrrc ii, iiia, or iiib).The authors of the article concluded, "independent risk factors for aneurysm recurrence after coil embolization with and without stent or balloon assistance were aneurysm diameter and postinterventional grading within the modified raymond-roy occlusion classification.Packing density interacted with the latter and was not independently associated to recurrence.".

• 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: 13509604
• MDR Text Key: 288797853
• Report Number: 2029214-2022-00201
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 02/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2022
• 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: 01/28/2022
• 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
• Patient Age: 54 YR
• Patient Sex: Female