MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.0MM X 17MM - PMAS; INTRACRANIAL ANEURYSM FLOW DIVERTER

Catalog Number	FDS40017
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fatigue (1849); Dizziness (2194)
Date of Event	07/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that post procedure, the patient begun having episodes of increased tiredness, fatigue, and weakness.The symptoms would completely resolve at times, however, when they would return the patient would be very unstable on her feet.The patient fell 2-3 times due to this weakness and imbalance.
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.Visual and functional inspections were not conducted due to the device 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.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 subject stent implantation date was (b)(6) 2022.Approximately "3 weeks ago the patient begun having episodes of increased tiredness, fatigue, and weakness.He states that the symptoms would completely resolve art times, however, when they would return the patient would be very unstable on her feet.He states that last week the patient fell 2-3 times due to this weakness and imbalance".Date of adverse event (ae) onset: (b)(6) 2025 date of ae resolution: (b)(6) 2025."episodic weakness, unknown etiology, no brain imaging, computed tomography (ct) abdomen reportedly compatible with acute appendicitis".This may have contributed to the reported event.An assignable cause of anticipated procedural complication will be assigned to the reported event: ¿patient complications¿ as a product related root cause does not apply and the issue is due to a known physiological effect of the procedure and/or patient condition noted with the directions for use, product labeling and/or risk documentation files.

• Brand Name: SURPASS EVOLVE 4.0MM X 17MM - 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: 22790234
• Report Number: 3008881809-2025-00444
• Device Sequence Number: 18340277
• Product Code: OUT
• UDI-Device Identifier: 07613327386530
• UDI-Public: (01)07613327386530(17)260608(10)22387925
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Report Date (Section B): 08/12/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/08/2023
• Device Catalogue Number: FDS40017
• Device Lot Number: 22387925
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/28/2025
• Initial Report FDA Received Date: 08/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/07/2020
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Weight: 95 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White