MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 AXIUM PRIME BRPL HLX; DEVICE, EMBOLIZATION, VASCULAR

Model Number	APB-2.5-6-HX-ES
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The axium coil remains implanted in the patient; the pushwire has not been returned for evaluation.Product analysis cannot be performed.The device was not returned; the reported event could not be confirmed.The cause of the event could not be conclusively determined from the reported information.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report of axium coil non-detachment.The patient was undergoing coil embolization for a fusiform aneurysm in the distal internal carotid artery (ica).It was noted that the blood flow was normal and the vessel tortuosity was normal.The devices were prepared as indicated in the ifu.It was reported that during the procedure, the axium coil failed to detach four times using an instant detacher.Afterward, manual detachment was attempted and failed on the first attempt.The second manual detachment attempt was successful.The axium was able to be placed.The pushwire was removed and there was reportedly no damage to it.No other issues were noted before or after non-detachment.There were no reports of patient injury in association with this event.

• Brand Name: AXIUM PRIME BRPL HLX
• Common Device Name: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 8500778
• Report Number: 2029214-2019-00328
• Device Sequence Number: 16816744
• Product Code: KRD
• UDI-Device Identifier: 00847536021051
• UDI-Public: 00847536021051
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K151447
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/10/2019

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: 12/09/2021
• Device Model Number: APB-2.5-6-HX-ES
• Device Lot Number: A752531
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2019
• Initial Report FDA Received Date: 04/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 31 YR