MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS 3.0MM X 21MM NO TIP- PMA; INTRACRANIAL COIL-ASSIST STENT

Catalog Number	M003UZAS30210
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the subject stent was attempted to be advanced through the microcatheter.The subject stent met resistance and the delivery wire/stent would not advance.The subject stent was returned for analysis and the device investigation revealed that the subject stent deployed prematurely during use.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 deployed within the lumen of the microcatheter at the proximal end.The stent delivery wire (sdw) and the introducer sheath were returned.An additional stent was also returned.The microcatheter was cut in order to retrieve the stent.The stent was deformed.The sdw was kinked/bent at the distal end.The introducer sheath was noted to be intact.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.Additional information received indicated that the device was prepared for use as per the directions for use.Continuous flush was set up and maintained throughout the clinical procedure.It was reported that 'the first stent started to go into the microcatheter.Met resistance and could not advance.When attempting to pull back on the delivery wire, it broke.Dr nichols was able to pull the stent out of the microcatheter hub.The second stent was attempted through the same microcatheter.Again, resistance was met and the delivery wire/stent would not advance.A new microcatheter and third stent were successfully used and implanted'.Note: this complaint refers to the second stent that was used in the procedure.The stent was returned for analysis no longer loaded on the stent delivery wire (sdw).The stent was fully deployed inside the proximal lumen of a returned microcatheter.The stent could not be easily removed from the microcatheter lumen and the microcatheter shaft had to be cut in order to remove the stent.Once removed it was noted that the proximal end of the stent were deformed.The sdw was kinked/bent towards the distal end of the wire.The introducer sheath was intact.One possibility is that the introducer sheath was initially set up correctly as was reported in the gfe responses.However, it subsequently moved proximally prior to stent advancement out of the sheath.This is supported by the lack of damage noted to the distal tip opening of the sheath during visual inspection.If this were to occur, it is likely that, during advancement of the stent to transfer it from the sheath into the proximal end of the microcatheter lumen, the stent would partially deploy into the gap between the distal end of the sheath and the proximal end of the microcatheter lumen.The user would experience increased resistance during attempts to advance the stent into the microcatheter lumen.Upon realizing this (through increased resistance), the user normally attempts to withdraw the stent.During this action, and particularly if there is significant friction between the stent and the lumen of the microcatheter, the distal bumper of the sdw (which is smaller in diameter to the proximal bumper which is used to advance the stent) can slip through the stent, leaving the stent deployed prematurely inside the microcatheter.This is the most likely explanation for the damage/observations noted during analysis and the information provided in the event description.An assignable cause of procedural factors has been assigned to the reported event ' stent difficult/unable to advance or pullback through catheter' and 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.

• Brand Name: NEUROFORM ATLAS 3.0MM 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: 25202858
• Report Number: 3008881809-2026-00307
• Device Sequence Number: 21036804
• Product Code: QCA
• UDI-Device Identifier: 07613327382211
• UDI-Public: (01)07613327382211(17)291117(10)25294527
• 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): 05/18/2026

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: M003UZAS30210
• Device Lot Number: 25294527
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/19/2024
• 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 Age: 64 YR
• Patient Sex: Female