MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 3.25MM X 12MM - PMAS; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number	FDS32512
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Impairment (2138); Stenosis (2263)
Date of Event	08/09/2021
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 to treat aneurysm in the left internal carotid artery-ophthalmic (c6 segment) on (b)(6) 2021.Post procedure the patient started to experience blurry vision initially only in the right eye on (b)(6) 2021.Updated information received on 18-apr-2021 indicates that this issue was in both the eyes.On (b)(6) 2022, the imr (designated cec member) has assessed the blurry vision changes in the patient had possible relation to the subject flow diverter, the procedure, the dual antiplatelet therapy and other devices used during the procedure.No other information is available.
Additional Manufacturer Narrative
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 there was blurry vision in the right eye, 18- april-2022: edc indicates that this new or worsening visual symptoms were in both eyes (bilateral), permanent visual impairment, hemianopia, nihss=1 greater than 24 hours, site reports in edc that no action or treatment was given for the ae.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.
Event or Problem Description
It was reported that in the clinical trial the subject flow diverter was implanted in a patient to treat aneurysm in the left internal carotid artery-ophthalmic (c6 segment) on (b)(6) 2021.Post procedure the patient started to experience blurry vision initially only in the right eye on 09-aug-2021.Updated information received on 18-apr-2021indicates that this issue was in both the eyes.On 11-apr-2022, the imr (designated cec member) has assessed the blurry vision changes in the patient had possible relation to the subject flow diverter, the procedure, the dual antiplatelet therapy and other devices used during the procedure.No other information is available.
Event or Problem Description
It was reported that in the clinical trial the subject flow diverter was implanted in a patient to treat aneurysm in the left internal carotid artery-ophthalmic (c6 segment) on (b)(6)2021.Post procedure the patient started to experience blurry vision initially only in the right eye on (b)(6)2021.Updated information received on (b)(6)2021 indicates that this issue was in both the eyes.On (b)(6)2022, the imr (designated cec member) has assessed the blurry vision changes in the patient had possible relation to the subject flow diverter, the procedure, the dual antiplatelet therapy and other devices used during the procedure.No other information is available.1-dec-2022: additional information received reported 50-75% stenosis noted within subject flow diverter on12 month follow-up imaging.
Additional Manufacturer Narrative
Additional information received on 1-dec-2022, reported that 50-75% stenosis within subject flow diverter was noted at the 12month follow up.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 'patient parent vessel stenosis' in this complaint.

• Brand Name: SURPASS EVOLVE 3.25MM 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: 14316141
• Report Number: 3008881809-2022-00206
• Device Sequence Number: 17351960
• Product Code: OUT
• UDI-Device Identifier: 07613327385625
• UDI-Public: 07613327385625
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 12/22/2022

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: 09/14/2023
• Device Model Number: FDS32512
• Device Catalogue Number: FDS32512
• Device Lot Number: 22452431
• 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: 04/11/2022
• Supplement Date Received by Manufacturer: 07/18/2022; 12/08/2022
• Initial Report FDA Received Date: 05/07/2022
• Supplement Report FDA Received Date: 08/14/2022; 12/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: EXCELSIOR XT-27 MICROCATHETER (STRYKER); SYNCHRO SELECT GUIDEWIRE (STRYKER)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Weight: 87 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American