MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.5MM X 12MM - PMAS; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number	FDS45012
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Headache (1880); Visual Disturbances (2140)
Date of Event	08/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is implanted in patient.
Event or Problem Description
It was reported in the clinical study that 16 days post successful procedure with the subject flow diverter stent, the patient experienced bilateral visual disturbances.The visual disturbances consisted of blurry vision and flashes of light and were associated with non serious headaches.The visual disturbances resolved on the same day and non serious headaches were reported to be resolving.No intervention was performed due to this event.No other information is available.
Event or Problem Description
It was reported in the clinical study that 16 days post successful procedure with the subject flow diverter stent, the patient experienced bilateral visual disturbances.The visual disturbances consisted of blurry vision and flashes of light and were associated with non serious headaches.The visual disturbances resolved on the same day and non serious headaches were reported to be resolving.No intervention was performed due to this event.No other information is available.Additional information was received on 12-nov-2021 and the reported visual disturbances were assessed by the cec as not related to the subject device.Therefore, this event does not meet reporting criteria anymore.
Additional Manufacturer Narrative
Report 1 of 2.B1 adverse event - no adverse event.B2 outcomes attributed to ae - none.H1 type of reportable event - not serious injury.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.
Additional Manufacturer Narrative
B1 adverse event - updated to adverse event.H1 type of reportable event - serious injury.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.It was reported that 1 day post procedure with the subject stent, the patient began experiencing headaches.No treatment was required and the adverse event is recovering/resolving.There was no permanent harm to the patient due to this adverse event.Additional information provided by the customer indicated that 2 flow diverter stents were used in the procedure because of pre-planned additional coverage at the aneurysm neck, the devices were successfully implanted, a microcatheter was used with the subject device, and no device deficiencies were noted.Based upon medical review, the harm observed in this complaint is anticipated in nature as per the device risk assessment.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 within the dfu, product labeling and/or risk documentation files, an assignable cause of anticipated procedural complication will be assigned to the reported events: patient headache non-serious and aneurysm recanalization requiring treatment.
Event or Problem Description
It was reported in the clinical study that 16 days post successful procedure with the subject flow diverter stent, the patient experienced bilateral visual disturbances.The visual disturbances consisted of blurry vision and flashes of light and were associated with non-serious headaches.The visual disturbances resolved on the same day and non-serious headaches were reported to be resolving.No intervention was performed due to this event.No other information is available.Additional information was received on 12-nov-2021 and the reported visual disturbances were assessed by the cec as not related to the subject device.Therefore, this event does not meet reporting criteria anymore.Update: additional information received on 30-may-2025 reported an incomplete aneurysm occlusion since target procedure on all follow up imaging.After 3-year angio, it was decided to retreat with elective embolization with another device that resulted in complete aneurysm occlusion, demonstrated on the (b)(6) 2024 angio.No complications to the patient were reported.This adverse event #6 was causally related to subject device and possibly related to disease under study.Outcome of this ae is recovered/resolved.

• Brand Name: SURPASS EVOLVE 4.5MM 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: 12580045
• Report Number: 3008881809-2021-00413
• Device Sequence Number: 6979201
• Product Code: OUT
• UDI-Device Identifier: 07613327386592
• UDI-Public: (01)07613327386592(17)240105(10)22670364
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P170024/S003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/23/2025

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: 01/05/2024
• Device Model Number: FDS45012
• Device Catalogue Number: FDS45012
• Device Lot Number: 22670364
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/10/2021
• Supplement Date Received by Manufacturer: 11/12/2021; 05/30/2025
• Initial Report FDA Received Date: 10/05/2021
• Supplement Report FDA Received Date: 12/08/2021; 06/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2021
• 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; Required Intervention
• Patient Age: 27 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White