MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS 3.0MM X 15MM NO TIP- PMA; INTRACRANIAL COIL-ASSIST STENT

Catalog Number	M003UZAS30150
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during procedure, the subject stent was not opening properly.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Event or Problem Description
It was reported that during procedure, the subject stent was not opening properly.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
Due to the automated manufacturing execution system (mes) there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not be performed.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.The reported complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.Additional information received indicated that the device was prepared for use as per the directions for use.The device was confirmed to be in good condition prior to use on the patient.Continuous flush was set up and maintained for the duration of the procedure.The tortuosity of the patient¿s anatomy was unknown.It was reported that 'the issue occurred while the device was being implanted in the patient.The stent did not appose the vessel distally.As the distal end was opening it did not appose the vessel walls, and it slid.The surgeon dragged the stent out of the patient.This is not typical.The stent is not resheathable, so to drag it out before it has been deployed is uncommon'.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause and the device was not returned, an assignable cause of undeterminable will be assigned to this complaint.

• Brand Name: NEUROFORM ATLAS 3.0MM X 15MM NO TIP- PMA
• Common Device Name: INTRACRANIAL COIL-ASSIST STENT
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 23657486
• Report Number: 3008881809-2025-00672
• Device Sequence Number: 4823697
• Product Code: QCA
• UDI-Device Identifier: 07613327382228
• UDI-Public: (01)07613327382228(17)290716(10)25076433
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P180031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/22/2026

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 Catalogue Number: M003UZAS30150
• Device Lot Number: 25076433
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/05/2025
• Supplement Date Received by Manufacturer: 01/13/2026; 04/30/2026
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 02/02/2026; 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: LIFT CATHETER (STRYKER).; SL-10 MICROCATHETER (STRYKER).
• Patient Sex: Unknown