MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.0MM X 15MM - PMAS; INTRACRANIAL ANEURYSM FLOW DIVERTER

Catalog Number	FDS40015
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	03/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Due to the automated manufacturing execution system (mes) system there are controls in the manufacturing process to ensure the product met specifications upon release.Visual and functional inspections were not performed due to the device was not returned.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 by the customer indicated the patient's current condition is good, both modified ranking scale (mrs) & national institute of health stroke scale (nihss) as 0.This was observed per core lab reading.Site reported >25-50% stenosis within flow diverter (fd).No other finding observed.There was no neurological deficit or sequelae noticed due to stenosis.The patient was not on any added medication or treatment due to the reported event.In the physician¿s opinion, just per core lab reading, no relevant adverse event reported.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 this complaint.
Event or Problem Description
It was reported that the initial subject stent implantation procedure at the internal carotid artery-ophthalmic (c6 segment) was carried out successfully via right radial artery.During follow up patient presents with 50-75% parent artery stenosis within the subject flow diverter evidenced on the digital subtraction angiography (dsa).The patient's current condition described as good, both mrs & nihss as 0.

• Brand Name: SURPASS EVOLVE 4.0MM 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
• 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: 20138538
• Report Number: 3008881809-2024-00400
• Device Sequence Number: 16940665
• Product Code: OUT
• UDI-Device Identifier: 07613327375190
• UDI-Public: 07613327375190
• 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
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/04/2024

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: 08/13/2023
• Device Catalogue Number: FDS40015
• Device Lot Number: 22396717
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/12/2024
• Initial Report FDA Received Date: 09/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/14/2020
• 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: 76 YR
• Patient Sex: Female