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 Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Transient Ischemic Attack (2109); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is 1 of 2 reports.This is a first report regarding neuroform atlas stent device.
Event or Problem Description
It was reported that post procedure, patient experienced with tia (transient ischemic attack).The patient was administered with medication and the outcome was resolved, without sequelae.Patient was returned to baseline.
Additional Manufacturer Narrative
Due to the automated manufacturing execution system (mes) system there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not be performed.The reported complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.Based upon medical review, the harm observed in the complaint is anticipated in nature as per the device risk assessment.The reported 'patient tia (transient ischemic attack)' is a known and anticipated complication to these types of procedures and patient condition and is listed as such in the device directions for use.Therefore, a probable cause of anticipated procedural complication was assigned to this event.
Event or Problem Description
It was reported that post procedure, patient experienced with tia (transient ischemic attack).The patient was administered with medication and the outcome was resolved, without sequelae.Patient was returned to baseline.
Event or Problem Description
Received additional information confirmed on 16-april-2026 that the site updated the relatedness to the subject stent device as unlikely which would be considered as unrelated (based on the nci guidelines).At this time, there is no information that reasonably suggests that there is any allegation against the subject stent device.Based on this review, the event does not meet the requirements for a complaint for the corresponding device.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.
Additional Manufacturer Narrative
B1 adverse event/product problem - corrected - no adverse event b2 outcomes attributed to ae ¿ corrected ¿ no other serious (important medical events), b5 executive summary: updated f10 / h6 device code grid: corrected f10 / h6 clinical signs code grid - health effect - clinical code - corrected f10 / h6 health impact code grid - health effect - impact code - corrected h6 investigation conclusions - conclusion code grid - corrected.Received additional information confirmed on 16-april-2026 that the site updated the relatedness to the subject stent device as unlikely which would be considered as unrelated (based on the nci guidelines).At this time, there is no information that reasonably suggests that there is any allegation against the subject stent device.Based on this review, the event does not meet the requirements for a complaint for the corresponding device.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.

• 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: 21962455
• Report Number: 3008881809-2025-00249
• Device Sequence Number: 7228014
• Product Code: QCA
• 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,Followup
• Report Date (Section B): 05/12/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: M003UZAS45210
• Device Lot Number: 24476558
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/16/2025
• Supplement Date Received by Manufacturer: 06/20/2025; 04/16/2026
• Initial Report FDA Received Date: 05/05/2025
• Supplement Report FDA Received Date: 07/02/2025; 05/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/09/2023
• 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: BALLOON CATHETER (STRYKER); BALLOON CATHETER (STRYKER).
• Outcome Attributed to Adverse Event: Other
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Weight: 107 LB