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

Model Number	APB-3-4-3D-ES
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/13/2019
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 coil was delivered into the aneurysm, and an attempt was made to detach the coil with the detacher, but it failed.The doctor attempted twice to detach the coil using the instant detacher.They did not attempt to detach the coil with another instant detacher.The manual detachment method was performed, but it failed also.One attempt was made to detach manually with the hypotube.The coil kept coming off with the delivery pusher without detaching.The coil was slowly drawn into the catheter and removed together with the microcatheter.The coil was detached in the microcatheter.There were no problems with the usage of the detacher and the method of manual detachment.The patient was undergoing surgery to treat a ruptured, saccular aneurysm located at the internal carotid artery with a max diameter of over 10mm and a neck diameter of over 4mm.It was noted the vessel tortuosity was normal.There were no patient symptoms associated with the event.The devices were prepared/flushed as indicated in the ifu.There was no resistance during delivery.The patient was ultimately treated with a competitor coil.No damage was seen on the devices.Ancillary device: sl10.
Additional Manufacturer Narrative
Device evaluation the axium prime coil (model: apb-3-4-3d-es lot: a803366) was returned for analysis without a dispenser coil and without an introducer sheath.There was no instant detacher, microcatheter, or accessories returned with the device.The axium prime coil was decontaminated.The actuator interface was found detached from the pushwire but retained by the release wire.No damages were found with the positive load indicator and the tack weld replacement crimps.Breaks were found on the break indicator and directly distal to the break indicator.All segments are retained by the release wire.This is indicative that mechanical and manual detachment attempts were made at these locations.Bends were found along the length of the pushwire directly distal to the break indicator.The coin was found pulled back from lumen stop; with the shield coil present and intact.The axium prime implant coil was returned already detached with damages and stretching observed throughout the implant coil.The detach element ball was visually acceptable.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.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 3D
• Common Device Name: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 8768867
• Report Number: 2029214-2019-00692
• Device Sequence Number: 2038701
• Product Code: KRD
• UDI-Device Identifier: 00847536021228
• UDI-Public: 00847536021228
• 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): 09/05/2019

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: 03/21/2022
• Device Model Number: APB-3-4-3D-ES
• Device Catalogue Number: APB-3-4-3D-ES
• Device Lot Number: A803366
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2019
• Initial Date Received by Manufacturer: 06/14/2019
• Supplement Date Received by Manufacturer: 08/15/2019
• Initial Report FDA Received Date: 07/08/2019
• Supplement Report FDA Received Date: 09/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1