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

Model Number	APB-2-2-3D-ES
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The axium prime coil was returned for evaluation inside of a cardboard shipping box and within a plastic ziploc bag.The contents of the ziploc bag were removed.The axium prime coil was found to be partially within the dispenser track and within the opened axium prime coil inner pouch.The axium prime coil outer carton and instructions for use (ifu) were not returned.The proximal tip of the pushwire was found to be still inside of the guidewire clip.The axium prime coil was removed from the dispenser track.The pushwire was found to be broken into two separate segments which were not retained together by the release wire.(proximal segment): the proximal pushwire segment was measured and found to be approximately 3.3cm in length with a bend at approximately 1.0cm from the proximal end.There was no release wire extending out from its broken distal end.(distal segment): the distal pushwire segment was measured and found to be approximately 185.0cm in length.The proximal tip of the pushwire was found to be broken with a broken release wire extending out for the length of approximately 2.0mm.Under the microscope, the implant t coil appeared to be in good condition; however, the implant coil was found to be detached within the introducer sheath.The pushwire outer diameter (od) was measured on the proximal end per (b)(4) and found to be within specifications.Specifications are (0.01200" +/- 0.00035").The actual od of the pushwire was measured to be 0.01890".Additionally, the guidewire clip inner diameter (id) and depth were measured per (b)(4) and found to be within specification.Specifications for the inner diameter are (0.6mm +0.1mm -0mm) and depth (specifications =10mm).The actual id of the guidewire clip was measured to be 0.63mm, and the depth was 10mm.No other anomalies were found.(b)(6).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report that during preparation the package of the coil was opened in which it was found that the proximal end of the pusher was stretched.As a result a new device was used to complete the surgery.The patient was undergoing embolization surgery to treat a brain tumor.There were no related patient symptoms.

• Brand Name: AXIUM PRIME BRPL 3D
• Common Device Name: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR; 9775 toledo way; irvine CA 92618
• MDR Report Key: 7922446
• Report Number: 2029214-2018-00821
• Device Sequence Number: 19245998
• Product Code: KRD
• UDI-Device Identifier: 00847536021174
• UDI-Public: 00847536021174
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 10/01/2018

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: 01/16/2021
• Device Model Number: APB-2-2-3D-ES
• Device Catalogue Number: APB-2-2-3D-ES
• Device Lot Number: A582361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2018
• Initial Report FDA Received Date: 10/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1