MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS ELITE FDS 3.25MM X 12MM - PMAS; INTRACRANIAL ANEURYSM FLOW DIVERTER

Catalog Number	FDSE32512
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when trying to deploy the subject stent, it would not re-sheath.The subject stent was stuck and wouldn't recapture so the system was removed.The subject device was replaced with an alternative device, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
Due to the automated mes (manufacturing execution system) 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.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.It was reported that ¿trying to deploy a subject stent as the subject stent would not re-sheath.It was stuck and had to be removed.No issues with the patient.It was prepped properly.We chose an alternative device and it was completed successfully.¿ additional information provided by the customer indicated the device prepared as per dfu.The anatomy was reported to 'fairly severe' tortuosity.A microcatheter standard straight was used in the procedure.The delivery catheter and pusher were purged with sterile saline and verified that fluid exits the end of the delivery catheter and pusher, the position of the delivery catheter was confirmed by visualizing the radiopaque markers, there was no reported resistance encountered during navigation of the subject stent to the target lesion, continuous flush was maintained throughout the procedure, the position of the subject stent implant was confirmed between the two marker bands, but the physician was unable to deliver the subject stent device to the target lesion, but was successful when a new device was delivered to the target lesion.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, a cause of undeterminable was assigned for the reported ¿flow diverter stent difficult/unable to re-capture into microcatheter¿.
Event or Problem Description
It was reported that when trying to deploy the subject stent, it would not re-sheath.The subject stent was stuck and wouldn't recapture so the system was removed.The subject device was replaced with an alternative device, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: SURPASS ELITE FDS 3.25MM X 12MM - PMAS
• Common Device Name: INTRACRANIAL ANEURYSM FLOW DIVERTER
• 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: 24791428
• Report Number: 3008881809-2026-00192
• Device Sequence Number: 9727643
• Product Code: OUT
• UDI-Device Identifier: 07613327582598
• UDI-Public: (01)07613327582598(17)271208(10)25353858
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P170024
• 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): 05/04/2026

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: FDSE32512
• Device Lot Number: 25353858
• 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: 03/18/2026
• Supplement Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 04/06/2026
• Supplement Report FDA Received Date: 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/09/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: XT27 MICROCATHETER STANDARD STRAIGHT (STRYKER).
• Patient Sex: Unknown