MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 5.0MM X 15MM - PMAS; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number	FDS50015
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the proximal end of the stent (subject device) failed to fully expand and partially deployed inside the patient¿s anatomy, it was recaptured/removed from the patient¿s anatomy.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that the proximal end of the stent (subject device) failed to fully expand and partially deployed inside the patient¿s anatomy, it was recaptured/removed from the patient¿s anatomy.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
H4 manufacturing date ¿ added.D4 expiration date - added.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 there was no damage noted on the stent or the stent delivery wire (sdw), the catheter tip was not shaped, continuous flush was maintained for the duration of the procedure, no excessive force was applied at any point while advancing the stent/flow diverter within the microcatheter, there was moderate resistance encountered during navigation of the flow diverter device to the target lesion, the stent was not prematurely deployed during use inside the patient¿s anatomy, the stent was partially deployed inside the patient¿s anatomy, the stent failed to fully expand and was recaptured/removed from the patient¿s anatomy, the flow diverter was not fully opposed to the vessel wall when it was deployed, the stent delivery microcatheter was retracted in a continuous movement while maintaining the position of the stent delivery wire and the patient¿s anatomy was moderately tortuous.The stent was recaptured and removed from the patient¿s anatomy.Access was through femoral.The size of the stent/flow diverter was appropriate for treatment site.The position of the stent/flow diverter was confirmed under fluoroscopy.The location of the stent/flow diverter when it failed to open was the ica (internal carotid artery).A stryker microcatheter was used in the procedure and the same microcatheter was used to finish the procedure.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause, a cause of undeterminable was assigned for the reported ¿stent partial deployment¿ and ¿stent failed/unable to open (when not implanted)¿.

• Brand Name: SURPASS EVOLVE 5.0MM X 15MM - 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: 15636982
• Report Number: 3008881809-2022-00516
• Device Sequence Number: 6436198
• Product Code: OUT
• UDI-Device Identifier: 07613327386691
• UDI-Public: 07613327386691
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 11/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/12/2025
• Device Model Number: FDS50015
• Device Catalogue Number: FDS50015
• Device Lot Number: 23538510
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/28/2022
• Supplement Date Received by Manufacturer: 11/14/2022
• Initial Report FDA Received Date: 10/20/2022
• Supplement Report FDA Received Date: 11/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: STENT (NON-STRYKER).; XT-27 CATHETER (STRYKER).
• Patient Sex: Unknown