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	Fracture (1260)
Health Effect - Clinical Codes	Coma (2417); Foreign Body In Patient (2687)
Date of Event	06/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is 1 of 2 reports (1st mdr).
Event or Problem Description
It was reported that during deployment of the stent (subject device) the delivery wire of the stent was fractured.Surgical removal was attempted but the fragments of fractured pieces remained within the patient's body and the patient is in coma.
Event or Problem Description
It was reported that during deployment of the stent (subject device) the delivery wire of the stent was fractured.Surgical removal was attempted but the fragments of fractured pieces remained within the patient's body and the patient is in coma.
Additional Manufacturer Narrative
This is 1 of 2 reports (1st mdr).D4 expiration date ¿ added.D4 gtin ¿ added.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.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not be performed.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 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.Additional information provided by the customer indicated that the device was prepared as per the dfu.It was reported that 'outer package not in perfect shape (box compressed, ink smeared)'.The device was confirmed to be in good condition once it had been removed from the box.The tortuosity of the patient's distal anatomy was described as 'high'.It was reported that 'during procedure the microcatheter and stent delivery wire fractured inside the patient during stent deployment.The proximal pieces were removed.Procedure was stopped; patient was kept on dual anti platelets.Surgical removal was attempted but the fragments of fractured pieces remained in patient's body, the patient is in coma'.In the follow-up good faith effort replies it is reported that no resistance was encountered during advancement of the stent within the catheter.However, there was resistance noted during stent deployment and the stent was reported to be 'stuck/jammed'.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause and the device was not returned, an assignable cause of undeterminable will be assigned to this complaint.

• 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: 22371619
• Report Number: 3008881809-2025-00367
• Device Sequence Number: 8025084
• Product Code: QCA
• UDI-Device Identifier: 07613327382129
• UDI-Public: (01)07613327382129(17)270104(10)23402124
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 09/16/2025

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: M003UZAS45300
• Device Lot Number: 23402124
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/09/2025
• Supplement Date Received by Manufacturer: 08/26/2025
• Initial Report FDA Received Date: 07/01/2025
• Supplement Report FDA Received Date: 09/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/06/2022
• 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).; SOFIA INTERMEDIATE CATHETER (NON-STRYKER).
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female