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

Model Number	FDS40012
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Activation Failure (3270)
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	03/11/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that during the procedure a small proximal ledge was left where the stent (subject device) wasn t opposing well which could have contributed to the distal stenosis on the edge of the stent (subject device) that the physician noticed at a 12-month follow-up.The procedure was completed successfully.
Event or Problem Description
It was reported that during the procedure a small proximal ledge was left where the stent (subject device) wasn¿t opposing well which could have contributed to the distal stenosis on the edge of the stent (subject device) that the physician noticed at a 12-month follow-up.The procedure was completed successfully.Additional information indicated that the stent (subject device) wasn¿t opposing well due to vessel stenosis preventing the subject stent from remaining open and not that the subject stent failed.
Additional Manufacturer Narrative
F10 / h6 device code grid/medical device problem code - updated h3 other text : the device is not available to manufacturer.
Additional Manufacturer Narrative
Due to the automated mes (manufacturing execution system) system there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not 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 that the procedure was completed successfully.The devices performed as intended.During the procedure a small proximal ledge was noted upon deployment which may have contributed to the reported event.When imaging was done immediately post procedure to show that the flow diverter was fully open, there was a small proximal ledge left where the device wasn¿t apposing well.In the physician¿s opinion, the event was related to the subject device and the device caused stenosis.It is unknown if access was through radial or femoral artery.The anatomical location where the issue occurred was the ica (internal carotid artery).The anatomy was not tortuous.The patient did not have a history of atherosclerotic disease.The patient was female, 58 years old.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 this complaint.
Event or Problem Description
It was reported that during the procedure a small proximal ledge was left where the stent (subject device) wasn¿t opposing well which could have contributed to the distal stenosis on the edge of the stent (subject device) that the physician noticed at a 12-month follow-up.The procedure was completed successfully.Additional information indicated that the stent (subject device) wasn¿t opposing well due to vessel stenosis preventing the subject stent from remaining open and not that the subject stent failed.

• 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: 13885347
• Report Number: 3008881809-2022-00142
• Device Sequence Number: 13700852
• 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,Followup,Followup
• Report Date (Section B): 06/24/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/20/2023
• Device Model Number: FDS40012
• Device Catalogue Number: FDS40012
• Device Lot Number: 22294996
• 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: 03/11/2022
• Supplement Date Received by Manufacturer: 04/18/2022; 06/23/2022
• Initial Report FDA Received Date: 03/24/2022
• Supplement Report FDA Received Date: 04/18/2022; 06/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2020
• 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: 58 YR
• Patient Sex: Female