MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.0MM X 17MM - PMAS; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number	FDS40017
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Headache (1880); Eye Pain (4467); Swelling/ Edema (4577)
Date of Event	01/06/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that post procedure with the subject flow diverter stent on (b)(6) 2023 patient developed 'moderate headache' following the procedure, which was as resolved with pain medication.The rationale for relationship to the study device was inferred as, 'flow diverter placement could cause headache'.The headache was reported to be possibly related to the study procedure, the study device, disease under study and underlying condition or disease.The 'headache' was resolved on (b)(6) 2023.It was also reported that two days post procedure with the subject flow diverter stent on (b)(6) 2023 the patients left eye became swollen and moderately painful, patient was put on two week course of dexamethasone medication.The swelling and pain in the left eye was reported to be possibly related to the study procedure and the study device.The rationale for relationship to the study device was inferred as possible venous congestion in orbit from mass effect from aneurysm as it thromboses.The swelling and pain in the left eye resolved on (b)(6) 2023.
Additional Manufacturer Narrative
The subject device is implanted inside the patient's vasculature.
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 by the customer indicated the procedure date was 04 jan 2023.The study device was implanted successfully to treat intracranial aneurysm in the left internal carotid artery-clinoid (c5 segment).There was no surgical delay or device deficiencies noted.An assignable cause of anticipated procedural complication will be assigned to the reported ¿patient inflammation¿ and ¿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.
Event or Problem Description
It was reported that post procedure with the subject flow diverter stent on 4-jan- 2023 patient developed 'moderate headache' following the procedure, which was as resolved with pain medication.The rationale for relationship to the study device was inferred as, 'flow diverter placement could cause headache'.The headache was reported to be possibly related to the study procedure, the study device, disease under study and underlying condition or disease.The 'headache' was resolved on 26-jan-2023.It was also reported that two days post procedure with the subject flow diverter stent on 6-jan-2023 the patients left eye became swollen and moderately painful, patient was put on two week course of dexamethasone medication.The swelling and pain in the left eye was reported to be possibly related to the study procedure and the study device.The rationale for relationship to the study device was inferred as possible venous congestion in orbit from mass effect from aneurysm as it thromboses.The swelling and pain in the left eye resolved on 24-jan-2023.

• Brand Name: SURPASS EVOLVE 4.0MM X 17MM - 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: 16475544
• Report Number: 3008881809-2023-00105
• Device Sequence Number: 7448106
• Product Code: OUT
• UDI-Device Identifier: 07613327386530
• UDI-Public: 07613327386530
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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,Followup
• Report Date (Section B): 03/29/2023

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: 05/09/2024
• Device Model Number: FDS40017
• Device Catalogue Number: FDS40017
• Device Lot Number: 22911878
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/08/2023
• Supplement Date Received by Manufacturer: 03/06/2023
• Initial Report FDA Received Date: 03/02/2023
• Supplement Report FDA Received Date: 03/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2021
• 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; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 46 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White