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

Model Number	APB-2-3-3D-ES
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The axium coil will not be returned for evaluation as it was implanted in the patient.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 marker dislodge.The patient was undergoing a coiling procedure.The reported device and the accessory devices were prepared as indicated in the ifu.A continuous flush was used during the case.It was reported that one axium coil was implanted in the patient.During placement, the coil alignment marker was noted to be not aligned to the catheter marker.There was reportedly no damage to the pushwire.Next, a second axium coil was attempted to be placed.The coil encountered resistance in the catheter and there was noted to be a "dot-shaped marker".The second coil was not implanted.No more coils were attempted.There were no reports of patient injury in association with this event.

• Brand Name: AXIUM PRIME BRPL 3D
• Common Device Name: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 8534291
• Report Number: 2029214-2019-00369
• Device Sequence Number: 13860270
• Product Code: KRD
• UDI-Device Identifier: 00847536021181
• UDI-Public: 00847536021181
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 04/20/2019

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: 09/19/2021
• Device Model Number: APB-2-3-3D-ES
• Device Lot Number: A710574
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2019
• Initial Report FDA Received Date: 04/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1