MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS ELITE FDS 3.25MM X 12MM - PMAS; INTRACRANIAL ANEURYSM FLOW DIVERTER

Catalog Number	FDSE32512
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during procedure the subject stent had apposition issues.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Event or Problem Description
It was reported that during procedure the subject stent had apposition issues.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
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.It was noted that the issue occurred "during the deployment of the stent, not after complete deployment.After complete deployment, everything looked great.Additional information also stated "this case came out absolutely great and was landed perfectly in the supraclinoid region, exactly where we needed it." additional information provided by the customer indicated the device was prepared for use as per the dfu.Continuous flush was set up and maintained throughout the clinical procedure.The patient¿s anatomy was very tortuous.Type 4 genu.Distal landing, at terminus, pushed more distal into m1 while pushing wire/loading in supraclinoid region.This was noted during the deployment of the stent, not after complete deployment.After complete deployment, everything looked great.The action taken due to the reported distal landing was the md quickly pulled the device back into place and continued with the case.This was feedback and not a complaint.In the physician¿s opinion, the reason for the issue was he felt they may have loaded slightly too much but also did not think it was enough to move the stent.The physician doesn¿t feel that the anatomy and/or location of intended area of treatment may have contributed to the reported event as they had good support and only landed in the straight segment of the ica (internal carotid artery) supraclinoid region.There were difficulties encountered during preparation/transferring/advancement /deployment of the subject device, that could have contributed to reported issue.The first stent they transferred from sheath to hub seemed to have been stuck in the catheter and then deployed in the hub.Second time around it went smoothly.This first stent/catheter was sent in for testing.Both forms refer to the same incident in the same patient.The procedure was completed successfully.Stent was successfully delivered from ica terminus to periophthalmic region.The patient was not affected as a result of the event.There was no surgical delay due to this event.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 to the reported issue ¿stent failed/unable to open¿ and 'unexpected movement of device'.

• Brand Name: SURPASS ELITE FDS 3.25MM 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: 21845718
• Report Number: 3008881809-2025-00208
• Device Sequence Number: 18466852
• Product Code: OUT
• UDI-Device Identifier: 07613327582598
• UDI-Public: (01)07613327582598(17)271006(10)25221754
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 06/17/2025

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 Catalogue Number: FDSE32512
• Device Lot Number: 25221754
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/24/2025
• Supplement Date Received by Manufacturer: 06/02/2025
• Initial Report FDA Received Date: 04/15/2025
• Supplement Report FDA Received Date: 06/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/07/2024
• 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: AXS CATALYST 5 CATHETER (STRYKER).; EXCELSIOR XT-27 CATHETER (STRYKER).; SURPASS ELITE FLOW DIVERTER (STRYKER).; SYNCHRO SELECT SOFT GUIDEWIRE (STRYKER).
• Patient Age: 55 YR
• Patient Sex: Female