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

Model Number	APB-1-2-3D-ES
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/02/2019
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 axium prime detachable coil system failed to detach at the target site.The patient was undergoing surgery for treatment of saccular, unruptured, a-com aneurysm with a max diameter of 3mm and a 2mm neck diameter.It was noted the patient's blood flow was normal and vessel tortuosity was moderate.It was reported that the product was prepared according to the instructions for use (ifu), inserted into the target site of the cerebral aneurysm, and attempted to be implanted.However, it failed in detachment even though the attempt was made twice with the instant detacher.The manual detachment method was attempted once, but it still failed detachment.The device was retrieved.When the healthcare provider (hcp) visually confirmed the coil part, the coil came off.There was no patient injury reported with the event.Ancillary devices include an echelon10 straight microcatheter.

• 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: 9189294
• Report Number: 2029214-2019-01023
• Device Sequence Number: 17054724
• Product Code: KRD
• UDI-Device Identifier: 00847536021112
• UDI-Public: 00847536021112
• 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): 10/14/2019

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 Model Number: APB-1-2-3D-ES
• Device Catalogue Number: APB-1-2-3D-ES
• Device Lot Number: A866279
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2019
• Initial Report FDA Received Date: 10/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1