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

Model Number	FDS45015
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	04/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that ten months post procedure on (b)(6) 2023 intimal hyperplasia, in-stent stenosis with flow delay in the right mca was noted with the subject flow diverter stent implanted to treat supraclinoid right ica aneurysm.Dsa diagnostic (interventional) procedure was performed on (b)(6) 2023.The in-stent stenosis was treated with percutaneous intervention with angioplasty and an additional stent was implanted to open-up the subject stent.It was noted that there is no obvious residual of previously seen right supraglenoid aneurysm.The intimal hyperplasia, in-stent stenosis with flow delay is noted to have a causal relationship with the study procedure and the study device.The rationale for relationship to the study device indicated is "md believes the flow diverter shortened a little which caused it to end at the end of cavernous curve and due to the device it resulted in malposition to the vessel wall resulting in the area of stenosis and flow turbulence." the ae outcome was indicated as resolved/recovered.
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.Additional information provided indicated the initial procedure date was (b)(6) 2022.Pre-procedure 3d dsa shows parent artery stenosis to be 0-25%.According to the physician "the flow diverter shortened a little which caused it to end at the end of cavernous curve and due to the device it resulted in malposition to the vessel wall resulting in the area of stenosis and flow turbulence." angioplasty and stenting over previous stent performed through surgical intervention much improved in-stent stenosis.There is no obvious residual of previously seen right supraclinoid aneurysm.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 "stenosis with stent deformation".The subject device is implanted inside the patient's vasculature.

• Brand Name: SURPASS EVOLVE 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: 16513734
• Report Number: 3008881809-2023-00118
• Device Sequence Number: 15026885
• Product Code: OUT
• UDI-Device Identifier: 07613327375244
• UDI-Public: 07613327375244
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P170024/S003
• 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
• Report Date (Section B): 03/09/2023

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: 07/12/2023
• Device Model Number: FDS45015
• Device Catalogue Number: FDS45015
• Device Lot Number: 22336560
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/15/2023
• Initial Report FDA Received Date: 03/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2020
• 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; Required Intervention
• Patient Age: 44 YR
• Patient Sex: Female
• Patient Weight: 88 KG
• Patient Ethnicity: Hispanic