MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS ELITE FDS 3.25MM X 25MM - PMAS; INTRACRANIAL ANEURYSM FLOW DIVERTER

Catalog Number	FDSE32525
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, the subject stent was unable to resheath into the microcatheter inside the patient's body.The subject stent was removed along with the microcatheter.The subject device was replaced, 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 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 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.It was reported that ¿flow diverter would not fully resheath¿.Additional information provided by the customer indicated the anatomy was reported to be average tortuous.The microcatheter and pusher were purged with sterile saline and verified that fluid exited the end of the delivery catheter and pusher.The flow diverter was not recaptured back into the microcatheter.When attempting to resheath the subject stent inside the body it wouldn¿t resheath.Stent was removed along with the microcatheter.The position of the microcatheter was confirmed by visualizing the radiopaque markers.The position of the flow diverter implant was confirmed between the two marker bands.There was resistance between the microcatheter and the pusher.There was no resistance encountered during navigation of the flow diverter device to the target lesion.There was no resistance during advancement of the stent delivery system through the patient¿s anatomy.A new stent was deployed to complete the procedure.In the physician¿s opinion, the cause of the reported issue may have been the large size of aneurysm which stent was deploying through.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 during the procedure, the subject stent was unable to resheath into the microcatheter inside the patient's body.The subject stent was removed along with the microcatheter.The subject device was replaced, 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 25MM - 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: 23829963
• Report Number: 3008881809-2025-00722
• Device Sequence Number: 9288184
• Product Code: OUT
• UDI-Device Identifier: 07613327582703
• UDI-Public: (01)07613327582703(17)271110(10)25266942
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P170024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2026

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: FDSE32525
• Device Lot Number: 25266942
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/01/2025
• Supplement Date Received by Manufacturer: 01/08/2026
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/11/2024
• 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: EXCELSIOR XT-27 MICROCATHETER(STRYKER).
• Patient Sex: Unknown