MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.0MM X 12MM - PMAS; INTRACRANIAL ANEURYSM FLOW DIVERTER

Catalog Number	FDS40012
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	04/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D4 expiration date - added.H4 manufacturing date ¿ added.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.It was reported that post procedure 12 month follow up imaging on (b)(6) 2023 shows 75-100 percentage stenosis within the subject flow diverter stent.Patient was put on brilinta and aspirin medication and patient is asymptomatic.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 the as reported "patient parent vessel stenosis".H3 other text : the subject device is implanted inside the patient's vasculature.
Event or Problem Description
It was reported that post procedure 12 month follow up imaging on (b)(6) 2023 shows 75-100 percentage stenosis within the subject flow diverter stent.Patient was put on brilinta and aspirin medication and patient is asymptomatic.It is indicated that the 'left high grade flow limiting stenosis' is causally related to the study procedure and the study device.The adverse event is possibly related to an underlying condition or disease.The adverse event outcome is not recovered/not resolved.

• Brand Name: SURPASS EVOLVE 4.0MM X 12MM - 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: 17553213
• Report Number: 3008881809-2023-00416
• Device Sequence Number: 4917353
• Product Code: OUT
• UDI-Device Identifier: 07613327386516
• UDI-Public: 07613327386516
• 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
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/15/2023

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: 01/05/2024
• Device Catalogue Number: FDS40012
• Device Lot Number: 22670367
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2021
• 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: 49 YR
• Patient Sex: Male