MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.5MM X 20MM - PMAS; INTRACRANIAL ANEURYSM FLOW DIVERTER

Catalog Number	FDS45020
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Headache (1880)
Date of Event	10/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the subject flow diverter stent was successfully implanted in a patient for aneurysm (4.95x3.04, neck 3,69) at left internal carotid artery-ophthalmic (c6 segment), with parent artery stenosis 0-25% on (b)(6) 2023.On (b)(6) 2023, patient developed adverse event ae# 3 intermittent headaches which are manageable without medications.No treatment required, event is not recovered/not resolved.This ae is possibly related to the study device, dapt and an underlying condition or disease and not related to other stryker devices, disease under study.No other information is available.
Additional Manufacturer Narrative
H3 other text : the device remains implanted in the patient.
Event or Problem Description
It was reported that the subject flow diverter stent was successfully implanted in a patient for aneurysm (4.95x3.04, neck 3,69) at left internal carotid artery-ophthalmic (c6 segment), with parent artery stenosis 0-25% on (b)(6) 2023.On (b)(6) 2023, patient developed adverse event ae# 3 intermittent headaches which are manageable without medications.No treatment required, event is not recovered/not resolved.This ae is possibly related to the study device, dapt and an underlying condition or disease and not related to other stryker devices, disease under study.No other information is available.
Additional Manufacturer Narrative
D4 expiration date - added.H4 manufacturing date ¿ added.Due to the automated mes system (manufacturing execution system) there are controls in the manufacturing process to ensure the product met specifications upon release.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.Based on the information provided in the complaint indicated the patient headache has currently not been recovered/not been resolved.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 as reported 'patient headache serious' 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 with the directions for use, product labeling and/or risk documentation files.

• Brand Name: SURPASS EVOLVE 4.5MM X 20MM - 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: 18303254
• Report Number: 3008881809-2023-00574
• Device Sequence Number: 20371375
• Product Code: OUT
• UDI-Device Identifier: 07613327375251
• UDI-Public: 07613327375251
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P170024/S003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2024

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: 02/24/2024
• Device Catalogue Number: FDS45020
• Device Lot Number: 22748470
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/15/2023
• Supplement Date Received by Manufacturer: 01/04/2024
• Initial Report FDA Received Date: 12/11/2023
• Supplement Report FDA Received Date: 01/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2021
• 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: 67 YR
• Patient Sex: Female