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

Model Number	QC-5-15-3D
Medical Device Problem Codes	Stretched (1601); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2021
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 broke or detached prematurely and stretched.The patient was undergoing a coil embolization procedure to treat an unruptured saccular aneurysm of the left posterior communicating artery.The aneurysm max diameter was 6mm and the neck diameter was 4mm.Blood flow and vessel tortuosity were normal.It was reported that the axium coil and all accessory devices used were prepared according to the instructions for use (ifu).During aneurysm filling it was discovered that the coil could no longer be manipulated as the coil had broken or detached prematurely and was stretched.There was no friction or other issue with delivery prior to the detachment.The physician did not reposition the coil or rotate the pusher.No attempt had been made at detachment.Continuous catheter flush was administered.The next coil was able to push the stretched portion of the first coil into the aneurysm sac and the procedure was successful.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: 11392359
• Report Number: 2029214-2021-00214
• Device Sequence Number: 1219296
• Product Code: KRD
• UDI-Device Identifier: 00847536030008
• UDI-Public: 00847536030008
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K081465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 03/01/2021

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: 11/11/2023
• Device Model Number: QC-5-15-3D
• Device Catalogue Number: QC-5-15-3D
• Device Lot Number: B116243
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2021
• Initial Report FDA Received Date: 03/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR