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

Model Number	APB-1.5-3-HX-ES
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Migration (4003)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for analysis.Since the device was not returned, we are unable to perform further root cause analysis.All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received report that the coil was delivered into the aneurysm, when the coil was pulled out for repositioning, it seemed that the coil had unraveled (stretched).Although it was collected together with the sl-10 microcatheter, the coil migrated from the aneurysm by several millimeters.When the delivery pusher was checked, it was judged that the coil was detached, and not unraveled,and it was confirmed by ct that the coil had unintentionally detached.A stent was used to mitigate the migrated portion of the coil and the procedure was completed.There was no damage to the pushwire and no resistance was felt when the coil was delivered through the catheter.The coil was only repositioned once.A continuous flush was used during the case.The devices were prepared and used per the instructions for use (ifu).This event occurred during the treatment of an unruptured left internal carotid artery aneurysm that was amorphous.The max diameter of 5mm and a neck width of 4mm.The anatomy was severe in tortuosity.The blood flow was normal.No patient injury occurred.

• 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: 8892432
• Report Number: 2029214-2019-00841
• Device Sequence Number: 18911792
• Product Code: KRD
• UDI-Device Identifier: 00847536020955
• UDI-Public: 00847536020955
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K151447
• 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): 08/14/2019

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: 07/09/2021
• Device Model Number: APB-1.5-3-HX-ES
• Device Lot Number: A672955
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2019
• Initial Report FDA Received Date: 08/14/2019
• 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: 70 YR