MAUDE Adverse Event Report: MICROVENTION, INC. STENT; Intracranial coil-assist stent

Model Number	LEV2522-PMA
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to the manufacturer and the investigation is ongoing.Upon completion of the investigation, a supplemental mdr report will be submitted.
Event or Problem Description
It was reported that the coil-assist stent was being used in an anterior communicating artery (acom) aneurysm embolization procedure.The stent introduced into the catheter without incident; however, when the physician tried to deploy it, the stent would not open distally.The physician then tried to recapture the stent and was not able to.The physician removed the entire stent/catheter system and use a different device to complete the procedure.There was no report of injury to the patient, who was reported in a stable condition.

• Brand Name: STENT
• Common Device Name: Intracranial coil-assist stent
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 25437285
• Report Number: 2032493-2026-00369
• Device Sequence Number: 18722503
• Product Code: QCA
• UDI-Device Identifier: 00842429117767
• UDI-Public: (01)00842429117767(11)240617(17)270531(10)0001475043
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P170013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2026

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 Model Number: LEV2522-PMA
• Device Catalogue Number: LEV2522
• Device Lot Number: 0001475043
• Date Returned to Manufacturer: 05/29/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2026
• Supplement Date Received by Manufacturer: 08/17/2026
• Initial Report FDA Received Date: 06/08/2026
• Supplement Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2024
• 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
• Patient Sex: Unknown