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

Model Number	APB-2.5-4-3D-ES
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The axium coil has not been returned for evaluation; product analysis cannot be performed.The device was not returned; the reported event could not be confirmed.The cause of the event could not be conclusively determined from the reported information.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report of axium coil non-detachment.The patient was undergoing coiling of an 8mm aneurysm.The patient¿s vasculature was mild in tortuosity.The devices were prepared and used per the ifu.It was reported that during the procedure, 10 coils had been placed in the aneurysm.An 11th coil (axium prime) was attempted to be placed.At detachment, the coil could not be detached.The instant detacher used was new and had been used 2-3 prior to non-detachment.Manual detachment was attempted once.No force was applied to pull the wire.The coil was removed.There was no damage to the pushwire.The procedure was completed using a new coil.No patient injury was reported as a result of the event.
Additional Manufacturer Narrative
The axium coils pusher was returned for analysis without the implant coil, instant detacher, microcatheter, or the accessories device.The ai, coupler tube and positive load indicator appeared to be separated and missing from the proximal end of the pusher.The pusher found to be broken at the break indicator but retained by the release wire; it appeared that manual detachment attempted at this location.Kinks and bends found along the length of the pusher.The coin was not present and was missing from the lumen stop; with the shield coil was intact but stretched.The implant coil was already detached and not returned for investigation.The inner diameter of the lumen stop and the inner diameter of the retainer ring were found to be visually acceptable.The lumen stop inner diameter (id) was measured and found to be within specification.The retainer ring inner diameter (id) was measured and found to be within specification.All other subassemblies appeared to be normal.No other anomalies were observed.Based on the analysis performed, the axium prime coil was not confirmed to have non-detachment as the pusher was returned with the implant coil already detached.Based on the returned device, there was evidence of manual detachment attempt to detach the coil as the pusher was broken at the break indicator.In addition, the pusher was bent and kinked along its length, indicative of high tortuosity.Based on the returned device, there was no malfunction of the pusher or non-conformance to specification identified that led to the non-detachment.Since the ai, coupler tube, positive load indicator, implant coil and instant detacher were not returned; any contribution of the ai, coupler tube, positive load indicator, implant coil and instant detacher to the non-detachment could not be determined.Per the axium prime detachable coil and i.D.(instant detacher) instructions for use (ifu): directions for use: ¿if the coil does not detach after 3 attempts, discard the i.D.(instant detacher) and replace with a new i.D.(instant detacher).Also, in the rare event that the coil does not detach and cannot be removed from the implant delivery pusher, use the following steps for detachment.A.Grip the hypotube approximately 5 cm distal of the positive load indicator at the hypotube break indicator and bend the implant delivery pusher just distal to the hbi 180 degrees.B.Next straighten the pusher back, continue bending and straightening until the pusher tubing opens exposing the release element.C.Gently separate the proximal and distal ends of the open pusher.Then, under fluoroscopy, pull the proximal portion of the implant delivery pusher approximately 2-3 cm to confirm implant detachment per ifu.¿ 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 COIL
• Common Device Name: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 8471405
• Report Number: 2029214-2019-00261
• Device Sequence Number: 13810960
• Product Code: KRD
• UDI-Device Identifier: 00847536021204
• UDI-Public: 00847536021204
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K151447
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2019

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: 08/14/2021
• Device Model Number: APB-2.5-4-3D-ES
• Device Lot Number: A693103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2019
• Initial Date Received by Manufacturer: 03/04/2019
• Supplement Date Received by Manufacturer: 05/30/2019
• Initial Report FDA Received Date: 04/01/2019
• Supplement Report FDA Received Date: 06/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1