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	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2026
Type of Reportable Event	Malfunction
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 delivery wire (sdw) was returned, along with another sdw and a microcatheter.The introducer sheath was not returned.The stent was located within the proximal lumen of the microcatheter.The microcatheter was cut in order to retrieve the stent.There was an unknown material (possibly some sort of tubing like polytetrafluoroethylene (ptfe)) present on the distal end of the stent.All 3 marker bands were present on both ends of the stent.The sdw was kinked/bent at the distal end.The functional inspection was unable to be performed as the stent was returned in a deployed state.The reported event ¿stent difficult/unable to advance or pullback through catheter¿ could not be 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 the stents would not go through the subject microcatheter and there was no additional information provided by the customer.The stent delivery wire (sdw) was returned, along with another sdw and a microcatheter.The introducer sheath was not returned.The stent was located within the proximal lumen of the microcatheter.The microcatheter was cut in order to retrieve the stent.There was an unknown material (possibly some sort of tubing like ptfe) present on the distal end of the stent.The sdw was kinked/bent at the distal end.Based on the limited details provided, it is likely that unknown procedural factor(s) resulted in the user experiencing difficulty while attempting to advance the stent through the microcatheter.Upon recognizing this, (increased resistance while advancing), the user attempted to withdraw the stent.During this action, as the stent reached the proximal end of the microcatheter, it naturally began to open/deploy as it exited the lumen and entered the microcatheter hub.The distal bumper of the sdw (which is smaller in diameter than the proximal bumper used to advance the stent) then slipped through the stent, leaving it partially deployed inside the microcatheter.Additionally, tortuous anatomy may have contributed to the resistance encountered during advancement.However, as insufficient information was provided by the customer, a definitive root cause cannot be conclusively determined.This remains the most likely explanation for the damage and observations noted during the analysis, based on the available information.An assignable cause of procedural factors has been assigned to the reported event ¿stent difficult/unable to advance or pullback through catheter¿ and to the analysed event ¿stent deployed prematurely during use¿ , ¿stent deformed¿ and ¿sdw kinked/bent¿ 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 factors during use.
Event or Problem Description
It was reported that the subject stent would not go through the microcatheter.The subject stent was returned for analysis and was examined.During device investigation and analysis, it was discovered that the subject stent had deployed prematurely during use.There is no additional information available.

• 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: 24929832
• Report Number: 3008881809-2026-00233
• Device Sequence Number: 5381015
• Product Code: QCA
• UDI-Device Identifier: 07613327382174
• UDI-Public: (01)07613327382174(17)290521(10)24981155
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/20/2026

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: 24981155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2024
• 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: EXCELSIOR SL-10 MICROCATHETER (STRYKER)
• Patient Sex: Unknown