MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.5MM X 17MM - PMAS; INTRACRANIAL ANEURYSM FLOW DIVERTER

Catalog Number	FDS45017
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Stroke/CVA (1770); Headache (1880); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a follow up after a post-implantation procedure of the subject flow diverter stent the patient experienced sever headache, staggering, imbalance and a stroke.Magnetic resonance angiography (mra) was performed during which an acute lacunar infarct of the right central pons was discovered.The current patient's condition is recovering/resolving.
Event or Problem Description
It was reported that during a follow up after a post-implantation procedure of the subject flow diverter stent the patient experienced sever headache, staggering, imbalance and a stroke.Magnetic resonance angiography (mra) was performed during which an acute lacunar infarct of the right central pons was discovered.The current patient's condition is recovering/resolving.Update: additional information received on 23 may 2025 confirmed that the adverse event stroke is not related to the study device.
Additional Manufacturer Narrative
B1 adverse event/product problem - corrected - no adverse event.H1 type of reportable event - corrected - no serious injury.B2 outcomes attributed to ae - corrected - no adverse event.B5 executive summary - updated.Clinical signs code grid - updated.Health impact code grid - updated.Device code grid - updated.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 conducted due to the device was not returned.A labelling review and risk assessment could not be performed as there was no allegation of failure or malfunction against the device.It cannot be confirmed that the device met specification, as the device was not returned.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 there were no device deficiencies noted.The device was successfully implanted and completely covered the aneurysm neck.As there was no allegation of failure or malfunction against the device an assignable cause of undeterminable will be assigned to the reported complaint.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.

• Brand Name: SURPASS EVOLVE 4.5MM 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: 21940109
• Report Number: 3008881809-2025-00237
• Device Sequence Number: 8835954
• Product Code: OUT
• UDI-Device Identifier: 07613327386639
• UDI-Public: (01)07613327386639(17)230422(10)22240804
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P170024
• 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): 06/09/2025

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: 04/22/2023
• Device Catalogue Number: FDS45017
• Device Lot Number: 22240804
• 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: 04/09/2025
• Supplement Date Received by Manufacturer: 05/23/2025
• Initial Report FDA Received Date: 04/30/2025
• Supplement Report FDA Received Date: 06/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/23/2020
• 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: 60 YR
• Patient Sex: Male
• Patient Weight: 82 KG