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

Model Number	APB-1.5-2-3D-ES
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/05/2019
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 information that the axium implant could not be detached during an embolization procedure.Prior to the event, two target coils had ben implanted in the aneurysm with ¿simple technique¿.Then the reported axium prime coil was prepared as indicated in the instructions for use (ifu) and delivered through the sl10 microcatheter that was already in place in the aneurysm.The coil was placed inside the aneurysm and an instant detacher was used to detach the coil and that was when the reported event occurred.The physician had thought that the coil detached smoothly, but found the coil to move with the pushwire as it was being removed.The physician then attempted to detach the coil using the manual method (breaking of the hypotube, an alternative detachment method presented in the instructions for use) and pulled back the release wire for 3cm and then pulled back the pushwire, but the coil still came along.The physician pushed the pushwire to slightly exceed the second marker of the reverse t, but the coil still came along with the pushwire as it was pulled out and detached inside the microcatheter.At this point, the physician tried to push the coil into the aneurysm with the pushwire but one loop of the coil deviated into the parent vessel.The physician assessed that this was ok and proceeded to complete the procedure with a coil from another manufacture without further problems.2 attempts were made with the instant detacher, 1 attempt was made with the manual detachment method.The instant detacher was brand new out of box, no kink/damage was seen on the pushwire.There were no issues prior to the coil non-detachment.No patient injury was reported as a result of the event.The patient was undergoing embolization of an aneurysm measuring 3mm.The patient¿s vasculature was medium in tortuosity.Ancillary device: sl10 microcatheter.

• Brand Name: AXIUM PRIME BARE PL 3D
• Common Device Name: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 8570066
• Report Number: 2029214-2019-00405
• Device Sequence Number: 19229236
• Product Code: KRD
• UDI-Device Identifier: 00847536021143
• UDI-Public: 00847536021143
• 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
• Report Date (Section B): 05/01/2019

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: 08/22/2021
• Device Model Number: APB-1.5-2-3D-ES
• Device Catalogue Number: APB-1.5-2-3D-ES
• Device Lot Number: A697296
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2019
• Initial Report FDA Received Date: 05/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1