MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR AXIUM FRAMING COIL

Model Number	FC-4-8-3D
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/06/2018
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 coil would not detach.The physician attempted to detach the coil without the instant detacher 3 times, and manually 2 times.They did not attempt to detach it with another instant detacher.The patient was undergoing surgery to treat an unruptured, a-com aneurysm with a max diameter of 5mm and a neck diameter of 4.5mm.The vessel tortuosity was moderate.The devices were prepared as indicated per the ifu.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtrronic received a report that the coil would not detach.The physician attempted to detach the coil with the instant detacher 3 times, and manually 2 times.They did not attempt to detach it with another instant detacher.The patient was undergoing surgeryto treat an unruptured, a-com aneurysm with a max diameter of 5mm and a neck diameter of 4.5mm.The vessel tortuosity was moderate.The devices were prepared as indicated per the ifu.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The patient was undergoing surgery to treat an unruptured, a-com aneurysm with a max diameter of 5mm and a neck diameter of 4.5mm.The vessel tortuosity was moderate.The devices were prepared/flushed as indicated per the ifu.It was confirmed that the same instant detacher was used to detach other coils, and that there was no resistance during the delivery of the coil in the catheter.There was no damage to the pushwire after removing it form the patient.The patient was treated well with no related symptoms.

• Brand Name: AXIUM FRAMING COIL
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR; 9775 toledo way; irvine CA 92618
• MDR Report Key: 7798651
• Report Number: 2029214-2018-00735
• Device Sequence Number: 2447151
• Product Code: KRD
• UDI-Device Identifier: 00847536022898
• UDI-Public: 00847536022898
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/12/2018

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: 04/15/2021
• Device Model Number: FC-4-8-3D
• Device Catalogue Number: FC-4-8-3D
• Device Lot Number: A630031
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2018
• Supplement Date Received by Manufacturer: 08/28/2018; 09/12/2018
• Initial Report FDA Received Date: 08/20/2018
• Supplement Report FDA Received Date: 08/28/2018; 09/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1