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

Model Number	APB-6-12-HX-SS
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/23/2018
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 report that 2 axium prime coils and 1 concerto coil failed to detach.It was reported that upon delivery of the coil, detachment was attempted using the instant detacher (id), but the coil did not detach.Then detachment was attempted with the hypotube break method, but the coil did not detach.2 detachment attempts were made with the instant detacher and one attempt was made via the second detachment method.The pushwire was seated deep into the id when the detachment attempts were made.The devices were retrieved and removed from the anatomy.The coils were reported to have been prepared and used per the instructions for use (ifu).The catheter was flushed, and coils were hydrated per the ifu.Continuous flush was not used during the procedure.No patient injury was reported to have occurred.The id and the coils will be returned for analysis.No issues were reported with the id.The anatomy was moderate in tortuosity and the blood flow was normal.
Additional Manufacturer Narrative
The pusher was returned for evaluation within its inner pouch; inside a biohazard bag and shipping carton; with instant detachers.The proximal portion of the pusher appeared to be broken and separated with the release-wire extended out.In addition, the ai and positive load indicator were missing from the pusher; it appears the manual detachment method was performed in this location rather than the location specified in the ifu.The pushwire was found to be intact distal to the break indicator at the manual detachment location (via hypotube).There has been no attempt to detach utilizing the manual method at the break indicator location.There is no implant at the distal end of the pusher, it has been detached and there are no pieces of the implant remaining.No bend was found on the pusher.The coin was not located against the lumen stop and no damage; the coil shield is intact.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 0.00260¿ and found to be within specification (0.00220" minimum - 0.0029" maximum).The retainer ring inner diameter (id) was measured 0.00455¿and found to be within specification (0.00455"+/- 0.00010").All other subassemblies appeared to be normal and no other anomalies were observed.Based on the analysis findings and the reported event details, the customer report of ¿non-detachment¿ could not be confirmed.The event cause could not be determined as coil appeared to be detached from the pusher.All parts of the returned pushwire that could affect the detachment were found to be within specifications.In addition, the cause for the difficulty during detachment with the instant detachers could not be determined as no defect was found with the returned instant detachers.The instant detachers were successfully detached the in-house coils.The proximal portion of the pushwire found to be broken and separation with the ai and positive load indicator were missing from the pusher; it appears the manual detachment method was p erformed in this location rather than the location specified in the ifu.It is possible that the incorrect method of manual detachment may have contributed to the non-detachment experience.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.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 in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees 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 reporting pursuant to part 803.Medtronic objects to the use of these words and others like it 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 NEUROVA; 9775 toledo way; irvine CA 92618
• MDR Report Key: 8161126
• Report Number: 2029214-2018-01061
• Device Sequence Number: 19383917
• Product Code: KRD
• UDI-Device Identifier: 00847536008267
• UDI-Public: 00847536008267
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K081465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2019

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: 02/22/2021
• Device Model Number: APB-6-12-HX-SS
• Device Catalogue Number: APB-6-12-HX-SS
• Device Lot Number: A603174
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/23/2018
• Supplement Date Received by Manufacturer: 02/27/2019
• Initial Report FDA Received Date: 12/13/2018
• Supplement Report FDA Received Date: 03/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1