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

Model Number	APB-5-20-HX-SS
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2020
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 once the ancillary devices were in place, three coils were delivered: apb-5-20-hx-ss, apb-6-15-3d-ss, qc-7-30-3d in sequence.When pushing the apb-5-20-hx-ss, the pushwire kinked/broke in the distal segment.There was no friction during delivery noted, and a continuous flush had been used.A replacement coil was used to complete the procedure smoothly.It was indicated that all devices were prepared as per the instructions for use (ifu), and no patient symptoms or further complications were reported as a result of this event.The patient was undergoing surgery for treatment of a saccular, ruptured aneurysm of the right posterior communicating (pcom) artery with a max diameter of 10 mm and a 5 mm neck diameter.It was noted the patient's blood flow was normal and vessel tortuosity was moderate.Additional information received from the physician indicated that the pushwire was broken into two pieces, which were taken out by suction and the microcatheter.It is unknown if there were any other issues that resulted in the damage found.

• 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: 11091140
• Report Number: 2029214-2020-01370
• Device Sequence Number: 13631976
• Product Code: KRD
• UDI-Device Identifier: 00847536032354
• UDI-Public: 00847536032354
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K081465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/29/2020

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: 02/28/2023
• Device Model Number: APB-5-20-HX-SS
• Device Catalogue Number: APB-5-20-HX-SS
• Device Lot Number: A984979
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2020
• Initial Report FDA Received Date: 12/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR