MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 5.0MM X 15MM - PMAS; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number	FDS50015
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Ischemia Stroke (4418); Thrombosis/Thrombus (4440)
Date of Event	05/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device remains implanted inside the patient.
Event or Problem Description
It was reported that the procedure of subject flow diverting stent deployment in internal carotid artery was completed successfully on (b)(6) 2021.It was reported that 12- 24 hours post procedure, patient had stroke due to clotting around the subject flow diverting stent.Additional surgery was performed to treat the stroke.The subject stent remains inside the patient¿s internal carotid artery.No additional 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 device was not returned for analysis.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.It was reported that the patient suffered a stroke in the internal carotid artery 12-24 hours post procedure with the subject flow diverter.Additional information provided by the customer indicated that no anomalies were noted to the device prior to use, the device was prepared as per the dfu, and no difficulties were encountered during the procedure.The stroke occurred due to clotting around the stent post procedure.The patient was treated with additional surgery.No additional information was received.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 stroke' and 'patient vessel thrombosis' 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 directions for use, product labelling and/or risk documentation files.
Event or Problem Description
It was reported that the procedure of subject flow diverting stent deployment in internal carotid artery was completed successfully on (b)(6) 2021.It was reported that 12- 24 hours post procedure, patient had stroke due to clotting around the subject flow diverting stent.Additional surgery was performed to treat the stroke.The subject stent remains inside the patient¿s internal carotid artery.No additional information is available.

• Brand Name: SURPASS EVOLVE 5.0MM 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
• MDR Report Key: 12043155
• Report Number: 3008881809-2021-00268
• Device Sequence Number: 4259576
• Product Code: OUT
• UDI-Device Identifier: 07613327386691
• UDI-Public: 07613327386691
• 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): 09/16/2021

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: 10/04/2023
• Device Model Number: FDS50015
• Device Catalogue Number: FDS50015
• Device Lot Number: 22510589
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/28/2021
• Supplement Date Received by Manufacturer: 08/26/2021
• Initial Report FDA Received Date: 06/22/2021
• Supplement Report FDA Received Date: 09/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention