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

Model Number	QC-8-20-3D
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/10/2018
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 healthcare professional (hcp) attempted to detach the coil with an instant detacher but it would not detach.A manual detachment was then attempted but the coil remained undetached.As a result the coil was removed from the patient and a new device used to complete the surgery.The patient was undergoing embolization surgery to treat a 14mm cerebral aneurysm.As a result of the issue the procedure was extended less than 30 minutes.It was noted that there were 3 coils implanted using the same microcatheter prior to the issue and no abnormalities were seen.There were no related patient symptoms.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: AXIUM 3D
• Common Device Name: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR; 9775 toledo way; irvine CA 92618
• MDR Report Key: 7693780
• Report Number: 2029214-2018-00627
• Device Sequence Number: 19229788
• Product Code: KRD
• UDI-Device Identifier: 00836462010420
• UDI-Public: 00836462010420
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 10/03/2018

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: 11/04/2019
• Device Model Number: QC-8-20-3D
• Device Catalogue Number: QC-8-20-3D
• Device Lot Number: A370687
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/11/2018
• Supplement Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 07/17/2018
• Supplement Report FDA Received Date: 10/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1