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

Model Number	QC-4-12-3D
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	02/28/2020
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 axium coil prematurely detached in the microcatheter.The patient was undergoing surgery for treatment of a saccular, ruptured aneurysm in the left internal carotid artery ophthalmic segment with a max diameter of 5.2mm and a 2.1mm neck diameter.It was noted the patient's blood flow and vessel tortuosity were normal.It was reported that during delivery of the axium coil, it automatically released in the microcatheter in advance, causing the coil to be left in the microcatheter.The surgeon withdrew the microcatheter, then took the coil out.The axium coil was replaced with a new coil to complete the procedure.It was noted that no surgical/medical intervention was required, there was no friction during deliver, the pushwire was not bent or broken, the coil was not repositioned or rotated, and a continuous flush had been administered.It was indicated that all devices were prepared as per the instructions for use (ifu), and no patient symptoms or further complications were reported as a result of this event.

• Brand Name: AXIUM 3D
• Common Device Name: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 9777243
• Report Number: 2029214-2020-00185
• Device Sequence Number: 2185438
• Product Code: KRD
• UDI-Device Identifier: 00847536029972
• UDI-Public: 00847536029972
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K081465
• 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): 03/02/2020

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: 11/14/2022
• Device Model Number: QC-4-12-3D
• Device Catalogue Number: QC-4-12-3D
• Device Lot Number: A933042
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2020
• Initial Report FDA Received Date: 03/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR