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

Model Number	QC-5-10-3D
Medical Device Problem Codes	Separation Failure (2547); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2021
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 information regarding an axium coil that failed to detach with detachment attempts and then detached prematurely within the catheter.The patient was undergoing a procedure for coil embolization treatment of a ruptured spindle shaped aneurysm of the right anterior c ommunicating artery (a-com) with a max diameter of 5mm.Blood flow and vessel tortuosity were normal.It was reported that the axium coil was the first used in the treatment of the a-com aneurysm.The device was prepared according to the instructions for use (ifu).The coil was delivered but could not be detached.Three detachment attempts were made with the instant detacher and one manual attempt with the hypotube but all failed.When the physician attempted to withdraw the coil, it detached within the catheter.The whole system was removed and the coil was protruding 1cm from the tip from the catheter tip.The same microcatheter was used with a new coil of the same model from a different lot which was successfully implant.The procedure was completed successfully.There was no harm or injury to the patient.

• Brand Name: AXIUM 3D
• Common Device Name: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 11310320
• Report Number: 2029214-2021-00166
• Device Sequence Number: 3786082
• Product Code: KRD
• UDI-Device Identifier: 00836462010369
• UDI-Public: 00836462010369
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 02/10/2021

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: 01/24/2022
• Device Model Number: QC-5-10-3D
• Device Catalogue Number: QC-5-10-3D
• Device Lot Number: A772153
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2021
• Initial Report FDA Received Date: 02/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1