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

Model Number	APB-2-2-3D-ES
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/25/2019
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 prematurely detached while the coil was raising.No surgical or medical intervention was required.The pushwire was not bent or broke.There was no friction/difficulty during delivery.The physician did not reposition the coil and did not attempt to detach the coil.They also did not rotate the delivery pusher during the procedure.Continuous flush was administered during the procedure.The patient was undergoing surgery to treat an unruptured, saccular aneurysm at the anterior communicating artery with a max diameter of 5mm and a neck diameter of 3mm.It was noted the vessel tortuosity was moderate.There were no patient symptoms associated with the event.The devices were prepared as indicated in the ifu.
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
The procedure was resumed by replacing the entire catheter system.
Additional Manufacturer Narrative
Only the axium prime pusher was returned; within a shipping box; within a sealed bio-pouch and within a dispenser coil.There was no implant coil, introducer sheath or accessories returned with the device.The pusher was found broken and kinked at the break indicator with the release wire extended out; along with the actuator interface, coupler tube and positive load indicator missing and not returned.It appeared that manual detachment was attempted at this location.Kinks and bends were found along the length of the pusher between ~0.3cm to ~156.4cm from the proximal end.The pusher was intact distal to the break indicator at the manual detachment location.The coin was not present at the lumen stop as it was pulled back.The shield coil was broken and not returned.Under the microscope, the outer jacket was then removed to gain access the coin.The coin was measured in 3 locations and was found to be within specifications.Measured 0.076mm @ 0.063mm; measured 0.077mm @ 0.127mm; measured 0.086mm @ 0.275mm.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 to be 0.00282¿ and found to be within specification (0.00220" minimum - 0.0029" maximum).The retainer ring inner diameter (id) was measured to be 0.00451¿and found to be within specification (0.00455"+/- 0.00010").No other anomalies were observed.Based on the analysis performed the axium prime coil was confirmed to have prematurely detached as the pusher was returned with the implant coil already detached.There was no malfunction of the pusher or non-conformance to specification that may have contributed to the pre-mature detachment.Since the ai, coupler tube, positive load indicator and implant coil were not returned, any contribution of the ai, coupler tube, positive load indicator and implant coil to the issue could not be determined.Based on the event description it is was not possible to ascertain the cause of the pre-mature detachment; however, based on the returned device, there was evidence of manual detachment attempts to detach the coil; with the coin pulled back from the lumen stop.The pulling back of the coin from the lumen stop may have contributed to the detachment of the implant coil from the pushwire.Furthermore, the pusher was bent and kinked along its length, indicative of high tortuosity.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: 8484230
• Report Number: 2029214-2019-00301
• Device Sequence Number: 19200407
• Product Code: KRD
• UDI-Device Identifier: 00847536021174
• UDI-Public: 00847536021174
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K151447
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/28/2019

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: 10/30/2021
• Device Model Number: APB-2-2-3D-ES
• Device Catalogue Number: APB-2-2-3D-ES
• Device Lot Number: A732978
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2019
• Supplement Date Received by Manufacturer: 03/27/2019; 06/24/2019
• Initial Report FDA Received Date: 04/04/2019
• Supplement Report FDA Received Date: 04/04/2019; 06/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1