MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 AXIUM PRIME BRPL 3D; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	APB-4-12-3D-SS
Medical Device Problem Codes	Separation Failure (2547); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report that the axium prime coil was unable to be detached, and then prematurely detached during removal.The patient was undergoing coil embolization for a dural arteriovenous fistula (davf).The patient's blood flow was normal, and the vessel tortuosity was severe.It was reported that the shunt point was the left ts porch, the feeder was the left middle meningeal artery (mma), the left occipital artery (oa) mastoidblunch and the left ss were occluded, so there was no antegrade blood flow.It was a state of the reflux to the superior sagittal sinus (sss) and straight sinus by considerable momentum.With the vein approach on the left, the coil embolization was started by advancing the catheter to the vein porch, which was the shunt point, beyond the occlusion part.There were no problems with the first 11 axium prime coils, but the twelfth could not be detached.Multiple attempts were made with the instant detacher, and one was made manually.A second instant detacher was not used as there were nor problems with the first one.When it was started to be removed, the coil detached where it came off about 1.5cm and drifted in the space inside the ts.The coil was collected with a snare, and the procedure was completed with other coils. the patient did not experience any injury.The devices were prepared according to the instructions for use (ifu).Ancillary devices include a fubuki 6f guide catheter, echelon 10 microcatheter, and chikai 14 guidewire.
Additional Manufacturer Narrative
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.
Event or Problem Description
Additional information was received.There was no kink/damage observed on the pushwire.The rep cannot figure out the cause because the previous investigation report has not been done yet.In the rep¿s personal opinion, it was a very small part, so it was thought that it was a product that required advanced manufacturing technology.Therefore, it was thought that the cause might be "unevenness in accuracy" by the manufacturer.Perhaps the relocation of the factory might also be related with it.Only axium and myclass had detachment error in recent coils.Axium's detachment system had a very simple and excellent structure, so the reason why it could not be detached was because the accuracy inside the detach link or the tip part of the pusher wire was low.Therefore, the wire came off, but it was said that the detach link was stuck for some reason.

• Brand Name: AXIUM PRIME BRPL 3D
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 12366193
• Report Number: 2029214-2021-01063
• Device Sequence Number: 4535422
• Product Code: KRD
• UDI-Device Identifier: 00847536008120
• UDI-Public: 00847536008120
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K081465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/10/2023
• Device Model Number: APB-4-12-3D-SS
• Device Catalogue Number: APB-4-12-3D-SS
• Device Lot Number: A990111
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/19/2021
• Supplement Date Received by Manufacturer: 08/27/2021
• Initial Report FDA Received Date: 08/25/2021
• Supplement Report FDA Received Date: 09/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1