MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS ELITE FDS 4.5MM X 15MM - PMAS; INTRACRANIAL ANEURYSM FLOW DIVERTER

Catalog Number	FDSE45015
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Codes	Thrombosis/Thrombus (4440); Unintended Radiation Exposure (4565)
Date of Event	11/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the stent (subject device) was used in the medical procedure.However, after deployment of the stent the proximal section of the stent fish mouthed.The physician used different techniques using balloon, microcatheter to open the stent, however ended up by implanting another snare stent to open the proximal section of the subject stent.The physician reported formation of clot near the stent thus additional medications were provided to the patient.The procedure was delayed for several hours, and the patient was kept on additional radiation time.The procedure was reported to be completed, and the patient was reported to be well.
Additional Manufacturer Narrative
D4 ¿ expiration date ¿ added.D4 ¿ gtin ¿ updated.H4 ¿ manufacturing date - added.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 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 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 events could not be confirmed, and it cannot be confirmed that the device met specification, as the device was not returned.Additional information provided by the customer did not indicate any issues noted during unpacking or set up of the device, and the device was prepared as per dfu instructions.There was no indication of a user related issue.The anatomy was reported to be normal.A microcatheter with internal diameter 0.027 was used to advance the flow diverter.Access was through femoral.The patient received dual anti-platelet agents both pre and post treatment.The physician was flow diverting two small supraclinoid aneurysms.The physician stented from the right m1 into the right internal carotid artery.The stent fish mouthed on the proximal end a few minutes after the stent was deployed.It was apposed and open upon deployment.The physician was able to deliver the flow diverter device to the target lesion.There was no resistance encountered during navigation of the flow diverter device to the target lesion.They did not need to recapture or resheath during deployment.The flow diverter was implanted.The flow diverter was confirmed to be fully deployed under fluoroscopy during the procedure.There were no changes noted to the vessel wall at the implantation site.The preoperative type, shape, and size of the intracranial aneurysm was multi-lobular supraclinoid aneurysms about 3mm in size.The size of the flow diverter appropriate for treatment site was 4.5x15.There was a lot of troubleshooting and adjunctive devices needed to complete the procedure.He used various microcatheters, balloons, and a stent to open the fish mouthed portion.The associated devices used when the issue occurred were scepter balloon and elvis stent and integrilin needed to be given.What was meant by fish mouthing was narrowing of the stent luminal diameter due to unknown factors.The vessel did not taper.The adverse consequences due to the reported event were delayed filling in the middle cerebral artery branches of the patient, a lot of additional radiation time for the patient, several hours added to the case time, clot formation around the stent, additional medication given to patient.There were no changes observed in the size or shape of the aneurysm during follow-up.The patient¿s current condition is patient went home and is doing okay.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 event of ¿stent tapering¿.An assignable cause of anticipated procedural complication will be assigned to the reported event of ¿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.
Event or Problem Description
It was reported that the stent (subject device) was used in the medical procedure.However, after deployment of the stent the proximal section of the stent fish mouthed.The physician used different techniques using balloon, microcatheter to open the stent, however ended up by implanting another snare stent to open the proximal section of the subject stent.The physician reported formation of clot near the stent thus additional medications were provided to the patient.The procedure was delayed for several hours, and the patient was kept on additional radiation time.The procedure was reported to be completed, and the patient was reported to be well.

• Brand Name: SURPASS ELITE FDS 4.5MM 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: 23790429
• Report Number: 3008881809-2025-00704
• Device Sequence Number: 12190588
• Product Code: OUT
• UDI-Device Identifier: 07613327582888
• UDI-Public: (01)07613327582888(17)280318(10)25524627
• 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): 12/22/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: FDSE45015
• Device Lot Number: 25524627
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/19/2025
• Supplement Date Received by Manufacturer: 12/19/2025
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/20/2025
• 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: ELVIS STENT (NON STRYKER); EXCELSIOR XT 27 MICROCATHETER (STRYKER); SCEPTER BALLOON (NON STRYKER)
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 42 YR
• Patient Sex: Male