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 Codes	Entrapment of Device (1212); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the stent (subject device) was used in the medical procedure.However, the physician could not retrieve the delivery wire upon deployment of the subject device.Also, after stent deployment, when pulling the microcatheter out of the body, the operator realized that the stent delivery wire (sdw) was still inside and it looked stretched.The 2.5mm radio opaque (ro) marker of sdw was lodged in the proximal tines of the stent.While attempting to retrieve the delivery wire of the subject device, the delivery wire got broken and fractured.The physician removed the proximal part of the delivery wire however the distal was left in vivo thus the physician deployed another stent to tack down the broken delivery wire to the vessel wall.The procedure was completed with a delay of 30 minutes.No further information available.
Event or Problem Description
It was reported that the stent (subject device) was used in the medical procedure.However, the physician could not retrieve the delivery wire upon deployment of the subject device.Also, after stent deployment, when pulling the microcatheter out of the body, the operator realized that the stent delivery wire (sdw) was still inside and it looked stretched.The 2.5mm radio opaque (ro) marker of sdw was lodged in the proximal tines of the stent.While attempting to retrieve the delivery wire of the subject device, the delivery wire got broken and fractured.The physician removed the proximal part of the delivery wire however the distal was left in vivo thus the physician deployed another stent to tack down the broken delivery wire to the vessel wall.The procedure was completed with a delay of 30 minutes.No further information available.
Additional Manufacturer Narrative
D4 - lot/serial no.- corrected, d4 ¿ expiration date ¿ added, d4 ¿ gtin ¿ updated, d9 - product available to stryker - updated, d9 - returned to manufacturer on ¿ updated, h3 - device evaluated by mfg ¿ updated, h4 ¿ manufacturing date - added.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 in a broken/fractured condition, which is aligned with the event description.The introducer sheath and stent were not returned.The sdw proximal coil was stretched and broken/fractured.The sdw core wire was broken/fractured.The sdw was kinked/bent at the distal end.A functional inspection was not required as the damage was confirmed visually.The reported events of 'sdw broken/fractured during use' was confirmed during device analysis.The remaining reported events of 'sdw friction', 'sdw stuck in stent' and 'un-retrieved device fragment' could not be replicated.However, the analysis results are consistent with the reported event.The returned section of the subject stent failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device section.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 provided by the customer indicated that the device was prepared as per the dfu.There was no damage noted to the packaging prior to opening the packaging and the device was confirmed to be in good condition prior to use on the patient.Continuous flush was set up and maintained throughout the clinical procedure.The patients anatomy was reported to be 'very tortuous'.It was reported that ¿the subject stent was used, upon deployment physician the physician could not retrieve the delivery wire.Physician could not track microcatheter.Several attempts were made.After attempt of removal wire fractured and broke'.'the delivery wire of the subject stent got broken and left inside the vessel with an additional stent being deployed to tack down the fractured wire to vessel wall'.'there was no resistance in the microcatheter.Physician believed that she had pulled the wire back into the microcatheter and pulled the two out as a system.When pulling the microcatheter out of the body, she realized that the wire was still inside and the wire looked stretched.I left the room to get a better look in the control room and realized that the 2.5mm radio opaque (ro) marker was lodged in the proximal tines of the stent.Physician attempted to pull the wire which subsequently broke off.Proximal wire sent back for inspection but distal wire remained in-vivo and tacked down with an additional stent in the radial artery'.Based on the event description and the information provided by the user, it appears that there was no issue when transferring the stent from the introducer sheath into the lumen of the microcatheter.There was also no issue when advancing the stent to the distal part of the microcatheter but, due to the tortuosity of the target vessels, there was some additional force needed to deploy the stent.This was completed successfully.It appears that when the sdw was being retracted through the stent, part of the sdw became entangled with the deployed stent.Due to this resistance, the user applied force to try and retrieve the sdw and this most likely resulted in the damage noted.Based on review of all available information the as reported events of 'sdw broken/fractured during use', 'sdw friction', 'sdw stuck in stent' and 'un-retrieved device fragment' as well as the analysed events of ¿sdw broken/fractured during use, ¿sdw kinked/bent¿, ¿sdw deformed¿ 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 procedural factors during use.

• 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 ; 5104132500
• MDR Report Key: 24056827
• Report Number: 3008881809-2026-00015
• Device Sequence Number: 18497178
• Product Code: QCA
• UDI-Device Identifier: 07613327382204
• UDI-Public: (01)07613327382204(17)280728(10)24446429
• 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): 03/19/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: M003UZAS30240
• Device Lot Number: 2446429
• 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: 12/18/2025
• Supplement Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2023
• 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).; NEUROFORM ATLAS STENT (STRYKER).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female