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

Model Number APB-3-8-3D-ES

Device Problems Incomplete or Missing Packaging (2312); Detachment of Device or Device Component (2907)

Patient Problem No Patient Involvement (2645)

Event Date 03/17/2020

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report that the axium coil was detached upon opening the cover.There was no additional information provided, and no patient harm indicated.

Manufacturer Narrative

D10.Device available, return date - additional information g4.Date manufacturer received - additional information g7.Type of report - additional information h2.Follow-up type - additional information h3.Device evaluation, device returned - additional information h6.Evaluation codes - additional information, device evaluation h10.Additional manufacturer narrative - additional information, device evaluation the axium prime pushwire was returned for analysis.The axium prime pushwire was found broken proximal to the break indicator.The actuator interface, positive load indicator, part of the coupler tube and release wire were not returned for analysis.The break on the pushwire is indicative that a manual detachment was attempted.The axium prime pushwire was found bent from the proximal end.The coin and release wire were completely retracted out of the lumen stop and pusher.The shield coil was found intact and the implant coil was already detached and not returned for analysis.No other anomalies were observed.Based on the device analysis and reported information, the report of ¿premature detachment¿ could not be confirmed.The device was returned with the implant coil already detached.However, the pushwire was broken near the break indicator, the release wire and coin were retracted out of the lumen stop and the implant coil was detached as designed by the device.As the proximal section of the pushwire, the release wire and the implant coil¿s detach element were not returned for analysis, any contribution of the proximal section of the pushwire, release wire, and implant coil/detach element towards the ¿premature 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 BARE 3D
• Type of Device: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 9853549
• MDR Text Key: 196386748
• Report Number: 2029214-2020-00258
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 00847536021242
• UDI-Public: 00847536021242
• Combination Product (y/n): N
• PMA/PMN Number: K151447
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/07/2022
• Device Model Number: APB-3-8-3D-ES
• Device Catalogue Number: APB-3-8-3D-ES
• Device Lot Number: A763355
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2020
• Date Manufacturer Received: 05/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1