MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS ELITE FDS 4.5MM X 30MM - PMAS; INTRACRANIAL ANEURYSM FLOW DIVERTER

Catalog Number	FDSE45030
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Stroke/CVA (1770); Obstruction/Occlusion (2422); Speech Disorder (4415); Thrombosis/Thrombus (4440)
Date of Event	02/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent subject stent implantation on (b)(6) 2026, the subject stent failed to open at the proximal end thus, balloon angioplasty was performed.On (b)(6) 2026, patient presented with stroke symptoms due to m1 occlusion in distal stent and delayed thrombosis.The patient underwent mechanical thrombectomy to remove clot from m1.The patient had prolonged hospitalization for 1 week and had aphasia.
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.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 event description states "aneurysm was successfully flow diverted on (b)(6) 2026 with subject stent followed by balloon angioplasty to ensure good apposition.Patient presented to emergency department (ed) with stroke symptoms (b)(6) 2026.Patients underwent mechanical thrombectomy to remove clot from m1" additional information states the subject stent performed as intended but proximal end of the subject stent required balloon angioplasty to ensure good apposition, the patient presented 4 days post operation (delayed thrombosis -post operation day 4) with m1 occlusion in distal stent - treated with thrombectomy, the patient was switched from brilinta to prasugrel despite having pru of 94 on brilinta.It is most likely that the patient anatomical factors contributed to the reported event.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 to the reported issues 'stent failed/unable to open'.An assignable cause of anticipated procedural complication will be assigned to the reported ¿patient stroke¿, 'patient vessel thrombosis, 'patient vessel occlusion' 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.
Event or Problem Description
It was reported that the patient underwent subject stent implantation on (b)(6) 2026, the subject stent failed to open at the proximal end thus, balloon angioplasty was performed.On (b)(6) 2026, patient presented with stroke symptoms due to m1 occlusion in distal stent and delayed thrombosis.The patient underwent mechanical thrombectomy to remove clot from m1.The patient had prolonged hospitalization for 1 week and had aphasia.

• Brand Name: SURPASS ELITE FDS 4.5MM X 30MM - 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: 24532571
• Report Number: 3008881809-2026-00127
• Device Sequence Number: 12985516
• Product Code: OUT
• UDI-Device Identifier: 07613327582932
• UDI-Public: (01)07613327582932(17)271006(10)25221749
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 03/30/2026

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: FDSE45030
• Device Lot Number: 25221749
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2026
• Supplement Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 03/06/2026
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/07/2024
• 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: BALLOON CATHETER (UNKNOWN)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female