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

Model 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	12/20/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that in the clinical trial the subject flow diverter was implanted in a patient for aneurysm in left internal carotid artery-ophthalmic (c6 segment) on (b)(6) 2021.Post procedure the patient had a previous visit on (b)(6) 2021 for transient vision changes involving both the eyes, which resolved on its own on the same day.Ct and mri diagnostic tests performed came back normal as per site reporting.At the visit patient was prescribed norco 5-325 mg for fibromyalgia pain.On (b)(6) 2022, the imr (designated cec member) has assessed the transient vision changes in the patient had possible relation to the subject flow diverter, procedure and the dual antiplatelet therapy.No other information is available.
Additional Manufacturer Narrative
The device is not available to the manufacturer as the subject device was implanted inside the patient's vasculature.
Event or Problem Description
It was reported that in the clinical trial the subject flow diverter was implanted in a patient for aneurysm in left internal carotid artery-ophthalmic (c6 segment) on (b)(6) 2021.Post procedure the patient had a previous visit on (b)(6) 2021 for transient vision changes involving both the eyes, which resolved on its own on the same day.Ct and mri diagnostic tests performed came back normal as per site reporting.At the visit patient was prescribed norco 5-325 mg for fibromyalgia pain.On (b)(6) 2022, the imr (designated cec member) has assessed the transient vision changes in the patient had possible relation to the subject flow diverter, procedure and the dual antiplatelet therapy.No other information is available.
Additional Manufacturer Narrative
D4 expiration date - added.H4 manufacturing date ¿ added.Due to the automated mes 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.It was reported that transient vision changes, affected both eyes (indicated as bilateral).No abnormality on mir.However need results of ophthalmoscopy, fundoscopy fully evaluate.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 as reported 'patient neurological deficit' for this complaint.

• 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: 14315679
• Report Number: 3008881809-2022-00205
• Device Sequence Number: 5000678
• Product Code: OUT
• UDI-Device Identifier: 07613327386639
• UDI-Public: 07613327386639
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Report Date (Section B): 08/15/2022

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: 11/30/2023
• Device Model Number: FDS45017
• Device Catalogue Number: FDS45017
• Device Lot Number: 22622266
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/11/2022
• Supplement Date Received by Manufacturer: 07/18/2022
• Initial Report FDA Received Date: 05/07/2022
• Supplement Report FDA Received Date: 08/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2020
• 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: 58 YR
• Patient Sex: Female
• Patient Weight: 85 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White