MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS 3.0MM X 24MM NO TIP- PMA; Intracranial coil-assist stent

Catalog Number	M003UZAS30240
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the procedure while deploying the subject stent, the subject stent broke.The physician taked down the broken part of the subject stent left in the patient with another atlas device.No clinical consequences were reported to the patient due to this event.There is no additional information available.

• Brand Name: NEUROFORM ATLAS 3.0MM X 24MM 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 ; +1(510)413-2500
• MDR Report Key: 25519894
• Report Number: 3008881809-2026-00371
• Device Sequence Number: 21317223
• Product Code: QCA
• UDI-Device Identifier: 07613327382204
• UDI-Public: (01)07613327382204(17)301130(10)26006494
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 08/26/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: M003UZAS30240
• Device Lot Number: 26006494
• Was Device Available for Evaluation?: No
• 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: 05/29/2026
• Supplement Date Received by Manufacturer: 08/21/2026
• Initial Report FDA Received Date: 06/16/2026
• Supplement Report FDA Received Date: 08/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/02/2025
• 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: Required Intervention
• Patient Age: 40 YR
• Patient Sex: Male