MAUDE Adverse Event Report: WALLABY MEDICAL WALLABY AVENIR COIL SYSTEM

Model Number	18CFR12040
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was admitted for the embolization of 2 intracranial aneurysms.During the procedure, it was impossible to deliver the coil.The coil stretched and could not be completely inserted into the aneurysm.It was subsequently pressed against the wall of the petrous carotid artery and the supraclinoid internal carotid artery by the placement of two stabilization stents.Information relating to the patient: it was necessary to place an additional stent to try to resolve the issue.Dual antiplatelet therapy was administered to the patient.Hospitalization was prolonged.
Additional Manufacturer Narrative
A manufacturing document review was conducted for lot: wcs11713 of the wallaby avenir coil system.The review confirmed that the lot was manufactured, inspected, and released in compliance with all required specifications the lot was not associated with any other adverse events or complaints.Since the device was not returned to the manufacturer for evaluation, the alleged product discrepancy could not be confirmed.However, from the clinical information, it was suspected that the coil impossible to delivery is related to vessel tortuosity and microcatheter kink, which potentially cause the coil damage or stuck inside the microcatheter, preventing it to deliver out of microcatheter, and during retrieval, the coil get prematurely detached.

• Brand Name: WALLABY AVENIR COIL SYSTEM
• Common Device Name: WALLABY AVENIR COIL SYSTEM
• Manufacturer (Section D): WALLABY MEDICAL; 22901 mill creek drive; laguna hills CA 92653
• Manufacturer (Section G): SHANGHAI WALLABY MEDICAL TECHNOLOGIES CO., INC.; lane 299, kangwei road; pudong new area; shanghai, 20131 5; CH 201315
• Manufacturer Contact: nate knock ; 22901 mill creek drive; laguna hills, CA 92653 ; 9494809466
• MDR Report Key: 25157359
• Report Number: 3014644549-2026-00003
• Device Sequence Number: 9378626
• Product Code: HCG
• UDI-Device Identifier: 06970908210075
• UDI-Public: (01)06970908210075(17)301216(10)WCS11713
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K173711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/13/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 18CFR12040
• Device Lot Number: WCS11713
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/17/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown