MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS 4.5MM X 30MM NO TIP- PMA; INTRACRANIAL COIL-ASSIST STENT

Catalog Number	M003UZAS45300
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the aneurysm surgery, the subject stent was prematurely deployed about 5 inches from the distal tip of the microcatheter.The subject device was replaced, and procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Event or Problem Description
It was reported that during the aneurysm surgery, the subject stent was prematurely deployed about 5 inches from the distal tip of the microcatheter.The subject device was replaced, and procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
Section d4: expiration date, gtin- updated section h3: device evaluated by mfg: updated section h4: manufacturing date: 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 stent was received deployed within the lumen of the microcatheter, which is aligned with the event description.The stent delivery wire (sdw) and the introducer sheath were both not returned.The microcatheter had been cut in two places, which is aligned with the event description.The stent was located within the first 6cm of the microcatheter, measured from the proximal end.The stent was noted to have minor deformation towards the distal (open cell) end.All 3 marker bands were present at both ends of the stent.The functional analysis was unable to perform as the stent was returned in a deployed state.The reported event is covered in the device direction 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 as reported (ar) event ¿stent deployed prematurely during use' was confirmed during visual inspection.The analysis results are consistent with the reported event.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.Additional information provided by the customer indicated that the introducer sheath was properly inserted inside the microcatheter (mc) hub prior to stent transfer.There was no gap between the distal end of the introducer sheath and the proximal end of the mc shaft.It was reported that ¿stent detached in the microcatheter.Stent ended up about 5 inches from the distal tip of the microcatheter.The stent was returned for analysis in a deployed condition inside the lumen of the returned microcatheter.The stent was no longer loaded on the stent delivery wire (sdw).The microcatheter had been cut open and the stent was partially exposed, approximately 6cm from the proximal end of the microcatheter shaft.This is contradictory to the event description which states that the stent was located approximately 5 inches from the distal tip of the microcatheter.The stent was removed, and minor deformation was noted towards the distal end of the stent.The introducer sheath was not returned for analysis, and the sdw was also not returned for analysis.Given the event description and the condition (and location) of the stent, it is possible that the introducer sheath was initially set up correctly as reported in the follow-up gfe responses.However, the sheath might have inadvertently moved proximally prior to stent advancement out of the sheath.This movement can occur if the rotating hemostatic valve (rhv) vent cap is not tightened sufficiently on the introducer sheath.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 introducer sheath and the proximal end of the microcatheter lumen.The user will then experience resistance while attempting to advance the stent through the microcatheter, often resulting in damage to the stent and sdw.Upon realizing this through increased resistance, the user may then attempt to withdraw the stent.During this action the distal bumper of the sdw can slip through the stent, leaving the stent deployed prematurely inside the microcatheter.This is one possible explanation to explain the analysis findings.An assignable cause of procedural factors has been assigned to the as reported event ¿stent deployed prematurely during use¿ and as analyzed event ¿stent deployed prematurely during use, stent deformed¿ as this complaint appears to be associated with a product that met the manufacturers design and manufacturing specifications, but performance was limited due to procedural factors during stent transfer/advancement.

• Brand Name: NEUROFORM ATLAS 4.5MM X 30MM 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: 22470958
• Report Number: 3008881809-2025-00385
• Device Sequence Number: 7853628
• Product Code: QCA
• UDI-Device Identifier: 07613327382129
• UDI-Public: (01)07613327382129(17)300401(10)25551399
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 07/31/2025

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: M003UZAS45300
• Device Lot Number: 25551399
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/20/2025
• Supplement Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 07/10/2025
• Supplement Report FDA Received Date: 07/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2025
• 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