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

Model Number	APB-2-6-HX-ES
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Since the device was not returned, we are unable to perform further root cause analysis and the exact cause of the reported event is unknown.All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture.No corrective action.Monitoring and trending this type of event.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received report that during the coil procedure, the axium prime coil failed to detach.Repeated detachment attempts (5 times) were made with id-1-5, but it failed.2 manual detachment attempts also failed to separate the coil.The pushwire was pushed a little, and the tension was applied, but it still failed.When the device was being retrieved (without any action) it broke inside the aneurysm.It is unknown if the instant detacher was the problem.A second instant detacher was not used.The devices were prepared and used per the instructions for used (ifu).The patient was treated for a right internal carotid-posterior communicating artery, unruptured aneurysm that was saccular.The max diameter was 4 mm and the neck was 4 mm.The blood flow was normal, and the vessel anatomy was moderate in tortuosity.

• 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: 9670610
• Report Number: 2029214-2020-00102
• Device Sequence Number: 19563949
• Product Code: KRD
• UDI-Device Identifier: 00847536021013
• UDI-Public: 00847536021013
• 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: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/05/2020

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: 10/30/2021
• Device Model Number: APB-2-6-HX-ES
• Device Lot Number: A732663
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2020
• Initial Report FDA Received Date: 02/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1