MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS ELITE FDS 5.0MM X 15MM - PMAS; INTRACRANIAL ANEURYSM FLOW DIVERTER

Catalog Number	FDSE50015
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the subject flow diverter stent was implanted on (b)(6) 2026 and the patient developed hemiplegia on (b)(6) 2026.After the physician performed head computed tomographic scan, clot was confirmed to be present within the subject stent.Thus, mechanical thrombectomy was performed.Additional information received on 04-feb-2026 confirmed that there was unknown slippage of gastric sleeve and the clot formation was due to malabsorption of dual anti-platelet therapy (dapt).Subsequently, information received on 18-feb-2026 confirmed that the subject stent failed to open at the proximal end (proximal ledge) and a balloon angioplasty was performed.No clinical consequences were reported to the patient due to this event.
Event or Problem Description
It was reported that the subject flow diverter stent was implanted on (b)(6) 2026 and the patient developed hemiplegia on (b)(6) 2026.After the physician performed head computed tomographic scan, clot was confirmed to be present within the subject stent.Thus, mechanical thrombectomy was performed.Additional information received on 04-feb-2026 confirmed that there was unknown slippage of gastric sleeve and the clot formation was due to malabsorption of dual anti-platelet therapy (dapt).Subsequently, information received on 18-feb-2026 confirmed that the subject stent failed to open at the proximal end (proximal ledge) and a balloon angioplasty was performed.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
D4 expiration date: updated, d4 gtin: updated, h4 manufacturing date: updated.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.Additional information provided by the customer indicated the "aneurysm was flow diverted on (b)(6) 2026 with subject stent and patient developed hemiplegia on (b)(6) 2026.Head computerized tomography (ct) imaging was performed indicating clot within the subject stent and patient was brought in for a mechanical thrombectomy".Most likely cause of event was patient had unknown slippage of gastric sleeve, leaving malabsorption of dual antiplatelet medication leading to delayed thrombosis (per physician).The stent deployed as intended but delayed thrombosis occurred the following day, most likely due to malabsorption of dual antiplatelet medication.It was noted that ¿balloon angioplasty required for slight proximal ledge¿.The dfu states "after the entire implant has deployed, confirm full expansion under fluoroscopy and ensure that it has completely apposed the vessel wall.If the device is not fully apposed, consider using a balloon catheter to fully open it".It is most probable that the anatomy of the patient contributed to the reported event, therefore an assignable cause of procedural factors will be assigned to the reported ¿ stent failed/unable to open¿ as the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.

• Brand Name: SURPASS ELITE FDS 5.0MM X 15MM - 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: 24471647
• Report Number: 3008881809-2026-00113
• Device Sequence Number: 9615867
• Product Code: OUT
• UDI-Device Identifier: 07613327582970
• UDI-Public: (01)07613327582970(17)271120(10)25295314
• 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): 04/06/2026

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: FDSE50015
• Device Lot Number: 25295314
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/30/2026
• Supplement Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 04/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/21/2024
• 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).
• Patient Sex: Unknown