MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS 4.0MM X 21MM NO TIP- PMA; INTRACRANIAL COIL-ASSIST STENT

Catalog Number	M003UZAS40210
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The subject stent was returned for analysis and the device investigation revealed stent partial deployment.The subject device was replaced, and 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.During visual inspection the stent was received partially deployed from the distal end of the microcatheter.The stent delivery wire (sdw) was returned, the introducer sheath was not returned.The microcatheter was noted to be intact.The device was unable to be flushed.The stent was able to be deployed by advancing the sdw.Dried blood was present on the stent.Once dissolved, the stent deployed fully.The stent was deformed at the distal end.All 3 marker bands were present on both ends of the stent.The sdw was kinked/bent at the distal end.Dried contrast was present at the proximal end of the proximal bumper.During functional inspection the stent was able to be deployed by advancing the sdw.The reported event stent failed/unable to deploy was not replicated.However, the analysis results are consistent with the reported event.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.It was reported that when the microcatheter was pulled back to expose the stent over the aneurysm, the sent could not be deployed out of the microcatheter and no additional information was provided by the customer.During analysis, the stent was received partially deployed from the distal end of the microcatheter.The stent was able to be deployed by advancing the sdw.Dried blood was present on the stent.Once dissolved, the stent deployed fully.The stent was deformed at the distal end.The sdw was kinked/bent at the distal end.Dried contrast was present at the proximal end of the proximal bumper.In the case of this complaint, it is likely that the stent was transferred from the sheath into the microcatheter, and the stent was advanced to the distal end of the microcatheter without any issues (resistance or friction) reported.Therefore, it is highly likely that the deployment issue occurred as a result of some unknown procedural factor(s) and/or the target vessel tortuosity.Additionally, it is probable that continuous saline flush was not maintained, which may have caused increased friction within the microcatheter lumen, potentially interfering with stent expansion and deployment at the distal tip.The reported event stent failed/unable to deploy as well as the analyzed event stent partial deployment, stent deformed and sdw kinked/bent will be assigned as procedural factors as this complaint appears to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural and/or anatomical factors during use.

• Brand Name: NEUROFORM ATLAS 4.0MM X 21MM 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: 24200460
• Report Number: 3008881809-2026-00051
• Device Sequence Number: 5495285
• Product Code: QCA
• UDI-Device Identifier: 07613327382174
• UDI-Public: (01)07613327382174(17)300412(10)25574280
• 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
• Report Date (Section B): 01/28/2026

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: M003UZAS40210
• Device Lot Number: 25574280
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/07/2026
• Initial Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/14/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: EXCELSIOR SL-10 MICROCATHETER (STRYKER)
• Patient Sex: Unknown