MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.5MM X 17MM - PMAS; INTRACRANIAL ANEURYSM FLOW DIVERTER

Catalog Number	FDS45017
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Disturbances (2140)
Date of Event	09/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3 other text : the subject device is implanted inside the patient's vasculature.
Event or Problem Description
It was reported that, the subject flow diverter stent was successfully implanted in the patient on (b)(6) 2023.Post procedure on (b)(6) 2023 patient experienced blurred vision in the right eye.The rationale for relationship to the study device was indicated as: "the stent covered the ophthalmic nerve".It is indicated that the blurred vision is possibly related to the study procedure and the study device.The adverse event outcome is indicated as recovering/resolving and no treatment was provided to the patient for this adverse event.The mrs (modified rankin score) & nihss (national institute of health stroke scale) score noted was '0' at discharge on (b)(6) 2023.The mrs score of 1, nihss score of 3 score was noted on (b)(6) 2023.It is noted that the patient has a past medical history of hypertension, former smoker, localized headache, severe head trauma, depression/anxiety, diabetes, hearing loss, budd-chiari syndrome, kyphoscoliosis, peripheral venous insufficiency and craniotomy.
Additional Manufacturer Narrative
Due to the automated mes (manufacturing execution system) system there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device is not available; therefore, functional testing as well as visual 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.Additional information provided by the customer indicated the subject is recovering (not ended yet).Based upon medical review, the harm observed in the complaint is anticipated in nature as per the device risk assessment.An assignable cause of anticipated procedural complication will be assigned to the reported ¿ patient neurological deficit¿ 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 subject flow diverter stent was successfully implanted in the patient on (b)(6) 2023.Post procedure on (b)(6) 2023 patient experienced blurred vision in the right eye.The rationale for relationship to the study device was indicated as: "the stent covered the ophthalmic nerve".It is indicated that the blurred vision is possibly related to the study procedure and the study device.The adverse event outcome is indicated as recovering/resolving and no treatment was provided to the patient for this adverse event.The mrs (modified rankin score) & nihss (national institute of health stroke scale) score noted was '0' at discharge on (b)(6) 2023.The mrs score of 1, nihss score of 3 score was noted on (b)(6) 2023.It is noted that the patient has a past medical history of hypertension, former smoker, localized headache, severe head trauma, depression/anxiety, diabetes, hearing loss, budd-chiari syndrome, kyphoscoliosis, peripheral venous insufficiency and craniotomy.

• Brand Name: SURPASS EVOLVE 4.5MM X 17MM - 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: 18044839
• Report Number: 3008881809-2023-00525
• Device Sequence Number: 7468560
• Product Code: OUT
• UDI-Device Identifier: 07613327386639
• UDI-Public: 07613327386639
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P170024/S003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2023

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: 10/18/2025
• Device Catalogue Number: FDS45017
• Device Lot Number: 23973328
• 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: 10/13/2023
• Supplement Date Received by Manufacturer: 11/09/2023
• Initial Report FDA Received Date: 11/01/2023
• Supplement Report FDA Received Date: 11/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2022
• 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
• Patient Age: 55 YR
• Patient Sex: Female