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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	10/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the subject stent was successfully implanted on (b)(6) 2025.Approximately 7 days post procedure it was reported that the subject stent was occluded.A post operative thrombectomy was performed on (b)(6) 2025.No further information is available.
Event or Problem Description
It was reported that the subject stent was successfully implanted on (b)(6) 2025.Approximately 7 days post procedure it was reported that the subject stent was occluded.A post operative thrombectomy was performed (b)(6) 2025.No further information is available.
Additional Manufacturer Narrative
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 is not available; therefore, visual testing as well as functional testing cannot 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.It was reported that ¿reported that the stent occluded after the surgery, approximately 7 days post op.(b)(6) 2025: original case date.A post operative thrombectomy was performed (b)(6) 2025¿.Additional information provided by the customer indicated stent apposition was seemingly perfect.Thrombus was occluding the stent.The issue was noted verbally per physician.The procedure was performed without any issues.Smooth and straightforward.The stent was successfully implanted with full apposition to vessel wall after the procedure and confirmed under fluoroscopy.The patient was supposedly on dual anti platelet therapy (dapt) before and after the surgery.A patch test was not performed before the procedure to confirm that the patient is not allergic to the device.The patient was genetically tested for dapt sensitivity.The pre, during and post procedure anti-coagulant/antiplatelet/fibrinolytic regimen were aspirin, brilinta, eloquis.Heparinized saline was used.No observable clots during procedure.The physician does not allege any malfunction or nonconformance against the device.An assignable cause of anticipated procedural complication will be assigned to the reported ¿patient vessel thrombosis¿ 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 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: 23633147
• Report Number: 3008881809-2025-00668
• Device Sequence Number: 9336742
• Product Code: OUT
• UDI-Device Identifier: 07613327582598
• UDI-Public: (01)07613327582598(17)271208(10)25353858
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: P170024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2025

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 Catalogue Number: FDSE32512
• Device Lot Number: 25353858
• 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: 10/30/2025
• Supplement Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 12/12/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Female