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

Model Number	QC-9-30-3D
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	08/29/2020
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 during aneurysm coil embolization, the axium coil had early detachment.A solitaire ab was then used to retrieve the coil and remove it from the patient.It was unknown if there was any friction, if the pushwire was damaged, if there was repositioning, attempts to detach the coil, rotation of the pushwire, or if a continuous flush had been administered.It was also unknown if the devices were prepared per the instructions for use (ifu).There were no patient symptoms or complications reported, but the patient status was unknown.Ancillary devices include an echelon microcatheter, solitaire ab, rebar 27, four other coils.

• 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: 10493910
• Report Number: 2029214-2020-00893
• Device Sequence Number: 3583779
• Product Code: KRD
• UDI-Device Identifier: 00836462010451
• UDI-Public: 00836462010451
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K081465
• 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): 09/04/2020

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: 04/02/2022
• Device Model Number: QC-9-30-3D
• Device Catalogue Number: QC-9-30-3D
• Device Lot Number: A809669
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2020
• Initial Report FDA Received Date: 09/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 38 YR