MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 AXIUM FRAMING COIL; DEVICE, EMBOLIZATION, VASCULAR

Model Number FC-3.5-6-3D

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/22/2019

Event Type  Injury  

Manufacturer Narrative

Since the device was not returned, we are unable to perform further root cause analysis.All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received report that the axium coil unintentionally detached and migrated.Although an attempt was made to place the reported product, but it failed.When the coil was repositioned about twice, the coil was detached early in the state that about 2cm part of the coil remained in the catheter.Even when the pushwire was removed, the blood flow was strong with the coil remaining, and the reported product, which migrated from the aneurysm, flew distally.Attempt was made to remove it using a snare, but it failed, and the part eventually flowed close to m4.Then, dual antiplatelet therapy (dapt) was performed immediately, treatment was restarted for the target aneurysm with stent-assisted coiling, and then, the procedure was completed without problems.Since dapt was performed, no thrombosis was found in the m4 part where this product was present, and the patient is asymptomatic at the moment." this event occurred during the treatment of ruptured left internal carotid-posterior communicating artery (ic-pc) saccular aneurysm.The max and neck diameter were both 3.5mm.The blood flow was fast.The vessel tortuosity was moderate.The devices were prepared and used per the instructions for use (ifu).Ancillary device: sl10 j type.

Manufacturer Narrative

G7.Type of report - additional information h2.Follow-up type - additional information h3.Device evaluation; - no eval explain code h10.Additional manufacturer narrative - additional information; device evaluation it was reported that the axium coil unintentionally detached and migrated close to the m4 as it was being repositioned in the microcatheter.As the event was reportable to a regulatory authority and indicated a possible failure of a device, labeling, or packaging to meet any of its specifications, an investigation was required.Additional information was required to investigate the event and/or determine the cause of the event.The health care provider and the manufacturer representative were contacted to obtain additional event details.Response was received stating that there are no plans to remove the axium coil from the patient and the pushwire was discarded.As the device remains in the patient, no analysis could be performed.There was no indication that the event was related to a possible manufacturing issue, so a device history record review was not performed.Malposition of the axium coil can be due to poor coil choice and poor catheter position or technique.There is a warning in the ifu for axium that states: if resistance is encountered while withdrawing an axium¿ detachable coil, which is at an acute angle relative to the catheter tip, it is possible to avoid coil stretching or breaking by carefully repositioning the distal tip of the catheter at the ostium of the aneurysm, or just slightly inside the parent artery.Given that the anatomy was reported to be moderately tortuous, this suggests that stretching was probably related to tortuous anatomy and technical issues.The axium ifu also states the following: ¿due to the delicate nature of the axium¿ detachable coil, the tortuous vascular pathways that lead to certain aneurysms and vessels, and the varying morphologies of intracranial aneurysms, a coil may occasionally stretch while being maneuvered.Stretching is a precursor to potential malfunctions such as coil breakage and migration.And if axium¿ detachable coil repositioning is necessary, take special care to retract coil under fluoroscopy in a one-to-one motion with the implant pusher.If the coil does not move with a one-to-one motion, or repositioning is difficult, the coil has been stretched and could possibly break.Gently remove and discard both the catheter and coil.¿ the investigation determined that this was a known event.Common sequences of events and contributing factors that can lead to this known event are documented in the risk management file.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.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 FRAMING COIL
• Type of Device: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 9525993
• MDR Text Key: 188884217
• Report Number: 2029214-2019-01301
• Device Sequence Number: 1
• Product Code: KRD
• Combination Product (y/n): N
• PMA/PMN Number: K162704
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 02/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/06/2022
• Device Model Number: FC-3.5-6-3D
• Device Lot Number: A877947
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/24/2019
• Initial Date FDA Received: 12/27/2019
• Supplement Dates Manufacturer Received: 12/24/2019
• Supplement Dates FDA Received: 02/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR