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

Model Number	APB-2-3-3D-ES
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation the axium prime pusher was returned for analysis.There was no implant coil or instant detacher returned with the device.The actuator interface was loose on the coupler tube and still retained by the release wire.This is indicative that a mechanical detachment was attempted using an instant detacher.The break indicator was found intact, which is indicative that no manual detachment was attempted.No damages or irregularities were found with the pusher.The coin was found present and retracted away from the lumen stop; with the shield coil present and intact.An attempt to pull on the release wire caused the coin to retract easily without resistance.Based on the analysis performed, the customer report of ¿premature detach from non-detach¿ could not be confirmed.The pusher was returned with the implant coil already detached which is indicative of a potential 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 mechanical detachment attempt using an instant detacher.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.If information is provided in the future, a supplemental report will be issued.
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 the axium coil failed to detach within the aneurysm.The device was retrieved without issue.Once the device was removed, the coil fell on the floor from within the sl10 microcatheter.A second instant detacher was not used.Manual detachment was not attempted.No patient injury occurred.The devices were prepared and used per the instructions for use (ifu).

• 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: 9109657
• Report Number: 2029214-2019-00950
• Device Sequence Number: 3762179
• Product Code: KRD
• UDI-Device Identifier: 00847536031883
• UDI-Public: 00847536031883
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K151447
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2019

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: 06/19/2022
• Device Model Number: APB-2-3-3D-ES
• Device Lot Number: A851604
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2019
• Initial Date Received by Manufacturer: 09/20/2019
• Supplement Date Received by Manufacturer: 11/19/2019
• Initial Report FDA Received Date: 09/24/2019
• Supplement Report FDA Received Date: 12/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1