MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS 4.5MM X 21MM NO TIP- PMA; INTRACRANIAL COIL-ASSIST STENT

Catalog Number	M003UZAS45210
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the subject stent prematurely deployed during the procedure.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
H4 manufacturing date ¿ added.H3 device evaluated by mfg ¿updated.D4 expiration date - added.D9 product available to stryker ¿ updated.D9 returned to manufacturer on ¿updated.D4 gtin - updated.Due to the automated manufacturing execution system (mes) system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection the device was received.The reported lot number was confirmed from the packaging label.The stent delivery wire (sdw) was returned, the introducer sheath and the stent were not returned.The sdw was kinked/bent at the distal end.Functional inspection was not performed as only the sdw was returned.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 event 'stent deployed prematurely during use' could not be replicated as the stent delivery wire (sdw) was the only part of the stent system which was returned for analysis.However, the analysis results are consistent with the reported event.The device did not meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.The only information available for this event is that it was reported that 'stent prematurely deployed'.The only part of the stent system which was returned for analysis was the stent delivery wire (sdw) which was noted to be kinked/bent towards the distal end of the wire.In the case of this complaint it is not possible to determine what occurred as there is very little information available relating to the complaint event and only the sdw was returned for analysis.The reported event: 'stent deployed prematurely during use' as well as the analyzed event: ¿sdw kinked/bent¿ will be assigned procedural factors as this complaint appears to be associated with a product that met stryker design and manufacturing specifications and was reported to have been used in accordance with the dfu, but performance was limited due to some unknown procedural factors during use.
Event or Problem Description
It was reported that the subject stent prematurely deployed during the procedure.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: NEUROFORM ATLAS 4.5MM 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: 22288599
• Report Number: 3008881809-2025-00348
• Device Sequence Number: 15683810
• Product Code: QCA
• UDI-Device Identifier: 07613327382150
• UDI-Public: (01)07613327382150(17)290401(10)24880203
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 08/25/2025

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: M003UZAS45210
• Device Lot Number: 24880203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/28/2025
• Supplement Date Received by Manufacturer: 08/11/2025
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 08/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2024
• 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
• Patient Sex: Unknown