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

Model Number	QC-9-30-3D
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Unintended Movement (3026)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The axium coil has not been returned for evaluation.The device was not returned; the reported event could not be confirmed and an event cause could not be conclusively determined from the provided information.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that the implant coil prematurely detached as it was being halfway delivered into the aneurysm.The physician used the guidewire to push part of the coil into the desired location; however, a small part of the coil was in the parent vessel.The physician used a stent to press the coil against the vessel wall and the procedure was completed.The patient was undergoing embolization treatment of a ruptured saccular aneurysm measuring 12.1mm x 3.8mm located in the a3 segment of the anterior cerebral artery (aca).The patient¿s vasculature was minimal in tortuosity and the blood flow was normal.The pushwire was not bent or broken.There was no difficulty or friction during delivery and the physician did not reposition the coil.Continuous flush was administered and there was no rotation of the pushwire.

• Brand Name: AXIUM 3D
• Common Device Name: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR; 9775 toledo way; irvine CA 92618
• MDR Report Key: 8372255
• Report Number: 2029214-2019-00140
• Device Sequence Number: 1203105
• Product Code: KRD
• UDI-Device Identifier: 00836462010451
• UDI-Public: 00836462010451
• 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): 02/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/19/2021
• Device Model Number: QC-9-30-3D
• Device Catalogue Number: QC-9-30-3D
• Device Lot Number: A711130
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2019
• Initial Report FDA Received Date: 02/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 28 YR