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

Catalog Number	FDS32512
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Disturbances (2140); Stenosis (2263); Thrombosis/Thrombus (4440)
Date of Event	03/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that left internal carotid artery ica para clinoid aneurysm procedure was performed with the subject stent on (b)(6) 2023.Subsequent dca showed intimal hyperplasia, but it was stable on an 18-month dca so plavix was stopped.Aspirin 81 was maintained.Then patient came to ed for ipsilateral visual deficits and cta computed tomography angiography showed subject stent has thrombosed completely.Patient has mild symptoms, and no subsequent intervention occurred.No further information is available.
Additional Manufacturer Narrative
Due to the automated manufacturing execution system (mes) there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device is not available; therefore, visual testing as well as functional 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.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 this complaint.
Event or Problem Description
It was reported that left internal carotid artery ica para clinoid aneurysm procedure was performed with the subject stent on (b)(6) 2023.Subsequent dca showed intimal hyperplasia, but it was stable on an 18-month dca so plavix was stopped.Aspirin 81 was maintained.Then patient came to ed for ipsilateral visual deficits and cta computed tomography angiography showed subject stent has thrombosed completely.Patient has mild symptoms, and no subsequent intervention occurred.No further information is available.

• 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: 20563613
• Report Number: 3008881809-2024-00515
• Device Sequence Number: 15323882
• Product Code: OUT
• UDI-Device Identifier: 07613327385625
• UDI-Public: (01)07613327385625(17)231214(10)22643772
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P170024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2024

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: 12/14/2023
• Device Catalogue Number: FDS32512
• Device Lot Number: 22643772
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/10/2024
• Supplement Date Received by Manufacturer: 11/21/2024
• Initial Report FDA Received Date: 10/29/2024
• Supplement Report FDA Received Date: 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/15/2020
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown