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

Model Number	FDS45020
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Headache (1880)
Date of Event	10/22/2022
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 on (b)(6) 2022.Post procedure patient called the clinic complaining of post operative headaches since on (b)(6) 2022 that were not improving.Patient was taking tylenol and oxycodone since on (b)(6) 2022.Patient saw a different provider and noted post operative headaches had resolved on (b)(6) 2022.It is indicated that the headache was possibly related to the study procedure, study device and an underlying condition or disease.Additional comments provided states "post-procedure headaches requiring narcotic medication".The outcome of headaches is indicated as recovered/ resolved.
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, 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 on (b)(6) 2022.Per site reporting in the study device was implanted successfully, and procedure with no device deficiencies noted.The condition being treated was intracranial aneurysm.The anatomical location was right ica clinoid (c5 segment).An assignable cause of anticipated procedural complication will be assigned to the 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 h3 other text : the subject device is implanted inside the patient's vasculature.

• 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: 17151958
• Report Number: 3008881809-2023-00305
• Device Sequence Number: 20257877
• Product Code: OUT
• UDI-Device Identifier: 07613327375251
• UDI-Public: 07613327375251
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P170024/S003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/19/2023

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: 10/25/2024
• Device Model Number: FDS45020
• Device Catalogue Number: FDS45020
• Device Lot Number: 23265864
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/24/2023
• Initial Report FDA Received Date: 06/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2021
• 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: Required Intervention; Other
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 103 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White