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

Model Number	QC-2.5-6-3D
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	06/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The axium coil (model: qc-2.5-6-3d lot: a784485) was returned for analysis.The axium coil was decontaminated.The introducer sheath was found correctly assembled on the pushwire with the wavelock at the proximal end.No damages or abnormalities were found with the introducer sheath.The axium pushwire was found to be bent.The implant coil and polypropylene filament were broken off from the detach element and not returned for analysis.The detach element was still attached to the pushwire.Based on the device analysis and reported information, the report of ¿coil resistance/stuck in sheath¿ could not be confirmed as the implant coil was already broken off from the pushwire.In addition, the coil was observed to be prematurely detached from the pushwire; the cause for the premature detachment could not be conclusively determined.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that an axium implant coil could not be pushed out of the introducer sheath during a procedure.During preparation, the introducer sheath had been held vertically when the implant coil was pulled back inside during hydration.The coil was replaced to continue the procedure without any impact to the patient.The patient was undergoing embolization treatment of an unruptured saccular aneurysm measuring 3.6mm x 1.7mm located in the ophthalmic segment of the left internal carotid artery (ica).The vasculature was normal in tortuosity and the blood flow was normal.The axium coil was returned for analysis and found to be detached from the pushwire.

• 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: 8932633
• Report Number: 2029214-2019-00874
• Device Sequence Number: 242341
• Product Code: KRD
• UDI-Device Identifier: 00847536017269
• UDI-Public: 00847536017269
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 08/26/2019

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: 02/15/2022
• Device Model Number: QC-2.5-6-3D
• Device Lot Number: A784485
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2019
• Initial Report FDA Received Date: 08/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR