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

Model Number	APB-5-15-3D-SS
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Refer to the previous manufacturer report 2029214-2021-00345 for details pertaining to the initial report submitted on 2021-03-25.Additional information received indicated manufacturer's report 2029214-2021-00318 and 2029214-2021-00345 occurred during the same procedure with two different coils.New information received for manufacturer report 2029214-2021-00345 will now be submitted via this manufacturer report number.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report that the an axium prime coil prematurely detached.The patient was undergoing a coil embolization procedure to treat an unruptured saccular aneurysm of an anterior communicating artery.The aneurysm max diameter was 5mm and the neck diameter was 2.8mm.Blood flow and vessel tortuosity were normal.It was reported that after the microcatheter was in place during the surgery, the coil was formed into a hoop in the tumor cavity.During the process, the coil was automatically detached when it hadn't completely entered the tumor cavity.After it was clear that the coil was detached on its own, the microcatheter was withdrawn, and the tail of the coil was located in the internal carotid artery.A solitaire ab stent was used to successfully capture the coil outside the body.The main branches of the left internal carotid artery angiography were clearly shown, and there was no thrombosis.The microcatheter was guided by the guidewire into the tumor cavity to continue the embolization operation.The surgery was successfully completed, and the patient had no adverse reactions after the surgery.Additional information received reported that there was no kink/damage observed on the pushwire.

• Brand Name: AXIUM PRIME BRPL 3D
• Common Device Name: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 11708365
• Report Number: 2029214-2021-00472
• Device Sequence Number: 19720352
• Product Code: KRD
• UDI-Device Identifier: 00847536032040
• UDI-Public: 00847536032040
• 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): 04/22/2021

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: 01/05/2023
• Device Model Number: APB-5-15-3D-SS
• Device Catalogue Number: APB-5-15-3D-SS
• Device Lot Number: A955276
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2021
• Initial Report FDA Received Date: 04/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 50