MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.0MM X 25MM - PMAS; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number	FDS40025
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	08/23/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the subject flow diverter stent was implanted in the right ica to treat a paraophtalmic aneurysm in a patient.The subject stent played short and landed with a ledge and therefore a second stent was telescoped to land well in the horizontal cavernous.Upon six month post procedure follow-up the distal segment of the subject stent (first stent) showed stenosis (distal to distal end of second flow diverter stent).No additional information available.
Additional Manufacturer Narrative
The subject device is implanted inside the patient's vasculature.
Additional Manufacturer Narrative
Although the dhr could not be reviewed because the lot number remains unknown, due to the automated mes 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.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 this complaint.
Event or Problem Description
It was reported that the subject flow diverter stent was implanted in the right ica to treat a paraophtalmic aneurysm in a patient.The subject stent played short and landed with a ledge and therefore a second stent was telescoped to land well in the horizontal cavernous.Upon six month post procedure follow-up the distal segment of the subject stent (first stent) showed stenosis (distal to distal end of second flow diverter stent).No additional information available.

• Brand Name: SURPASS EVOLVE 4.0MM X 25MM - 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: 16355429
• Report Number: 3008881809-2023-00064
• Device Sequence Number: 17851664
• Product Code: OUT
• UDI-Device Identifier: 07613327375213
• UDI-Public: 07613327375213
• 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,Followup
• Report Date (Section B): 03/17/2023

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 Model Number: FDS40025
• Device Catalogue Number: FDS40025
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/16/2023
• Supplement Date Received by Manufacturer: 02/23/2023
• Initial Report FDA Received Date: 02/10/2023
• Supplement Report FDA Received Date: 03/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Unknown