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

Model Number	APB-3-8-HX-ES
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for analysis.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 or Problem Description
Medtronic received report that during the embolization of aneurysm by coils, axium prime 3x8 helical coil was delivered.However, upon the detachment attempt (2-3) with the instant detacher id, the coil failed to detach.The detachment attempt was made several times but failed.Manual detachment (2-3) was attempted multiple times but also failed.It was then decided to retrieve the coil by pulling on the delivery wire.Upon this maneuver, the coil separated.No patient injury occurred.This event occurred during the treatment of an anterior communicating artery (acom).The aneurysm was saccular, with a 5mm max diameter and 2.4mm neck.The blood flow was normal, and the anatomy was moderate in tortuosity.The reported device and the accessory devices were prepared as indicated in the instructions for use (ifu).
Additional Manufacturer Narrative
The axium prime pushwire was returned for analysis without a dispenser coil and without an introducer sheath.There was no implant coil, instant detacher, micro catheter, or accessories returned with the device.The axium prime pushwire was decontaminated.The actuator interface, coupler tube, positive load indicator and break indicator was broken from the pushwire and not returned for analysis.A segment approximately 2.2cm was broken off from the remaining proximal end of the pushwire, but retained together by the release wire.A bend was found on the pushwire and a kink was found on the pushwire near the distal end.The coin was found present and pulled back from the lumen stop; with the shield coil present but stretched.The implant coil was already detached and not returned for analysis.Under microscope, the jacket was removed to gain access to the coin and lumen stop.The coin was found to be visually acceptable with no damages.The lumen stop was found to be visually acceptable.The lumen stop inner diameter (id) was measured and found to be within specifications.The retainer ring was found occluded by blood and had to be soaked in enzyte overnight to dissolve the occlusion.The retainer ring was found to be visually acceptable and the inner diameter (id) was measured and also found to be within specifications.No other anomalies were observed.Based on the analysis performed, the customer report of ¿premature detach from non-detach¿ could not be confirmed.The pushwire was returned with the implant coil already detached which is indicative of premature detachment, however, it is not possible to confirm that the implant coil could not detach prior to this.Based on the returned device, there was evidence of manual detachment attempts.No non-conformance to specification were identified that could have led to the premature detachment from non-detachment.The pushwire was found bent and kinked, indicative of either high tortuosity or damage during return shipping to medtronic for analysis.The shield coil was found stretched.It is possible that a non-detach could occur due to the shield coil being wrapped around the coil shell or proximal end of implant coil, preventing the implant coil from detaching correctly.There is no indication that the event is related to a manufacturing issue, and a device history review was not requested, therefore a dhr review is not required.Since the implant coil and instant detacher were not returned; any contribution of the implant coil and instant detacher to the premature detachment from non-detachment could not be determined.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 PRIME BRPL HLX
• Common Device Name: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 8809231
• Report Number: 2029214-2019-00762
• Device Sequence Number: 342901
• Product Code: KRD
• UDI-Device Identifier: 00847536021099
• UDI-Public: 00847536021099
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2019

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: 03/13/2022
• Device Model Number: APB-3-8-HX-ES
• Device Lot Number: A798805
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2019
• Initial Date Received by Manufacturer: 07/12/2019
• Supplement Date Received by Manufacturer: 09/05/2019
• Initial Report FDA Received Date: 07/19/2019
• Supplement Report FDA Received Date: 09/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Weight: 75