MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS ELITE FDS 3.25MM X 17MM - PMAS; INTRACRANIAL ANEURYSM FLOW DIVERTER

Catalog Number	FDSE32517
Medical Device Problem Codes	Premature Activation (1484); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
This event was reported based on the physician's preference evaluation.During the procedure, the subject stent came off of the resheath pad while flipping the petals in the mca (middle cerebral artery).The operator was able to salvage the subject device by locking down the system and slowly pulling back to the landing zone.An angioplasty balloon was used post subject flow diverter stent deployment for proximal shelf.The procedure was completed successfully with subject device successfully covering the aneurysm neck.Resistance was encountered during navigation of the subject flow diverter device to the target lesion and during the subject flow diverter deployment.No clinical consequences were reported for the patient due to this event.
Additional Manufacturer Narrative
This 1 of 2 reports (1st mdr).
Additional Manufacturer Narrative
This 1 of 2 reports (1st mdr).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 the patient received dual anti-platelet agents prior to the procedure, post procedure.Access was through femoral.Tortuosity was on a scale of 3.There was a little resistance encountered during navigation of the flow diverter device to the target lesion.The position of the delivery catheter was confirmed by visualizing the radiopaque markers.The position of the flow diverter implant was confirmed between the two marker bands.There was resistance encountered during the flow diverter deployment.The stent opened and was apposed distally.Being the stent was off the resheath pad, the physician did not want to manipulate or push the device while deploying.Therefore, he unsheathed the device with understanding of having to post process.The proximal end was opened but not apposed when it was deployed.The flow diverter was recaptured/resheathed back during the procedure 1 time.Device came off resheathe pad when flipping the petals in the mca (middle cerebral artery aneurysm).There were no clinical consequence to the patient due to the reported 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 deployed prematurely during use¿, ¿stent failed/unable to open¿ and ¿stent friction¿.
Event or Problem Description
This event was reported based on the physician's preference evaluation.During the procedure, the subject stent came off of the resheath pad while flipping the petals in the mca (middle cerebral artery).The operator was able to salvage the subject device by locking down the system and slowly pulling back to the landing zone.An angioplasty balloon was used post subject flow diverter stent deployment for proximal shelf.The procedure was completed successfully with subject device successfully covering the aneurysm neck.Resistance was encountered during navigation of the subject flow diverter device to the target lesion and during the subject flow diverter deployment.No clinical consequences were reported for the patient due to this event.

• Brand Name: SURPASS ELITE FDS 3.25MM X 17MM - 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: 21351253
• Report Number: 3008881809-2025-00078
• Device Sequence Number: 7959167
• Product Code: OUT
• UDI-Device Identifier: 07613327582635
• UDI-Public: (01)07613327582635(17)270728(10)25077823
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 03/18/2025

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: FDSE32517
• Device Lot Number: 25077823
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/30/2025
• Supplement Date Received by Manufacturer: 02/27/2025
• Initial Report FDA Received Date: 02/10/2025
• Supplement Report FDA Received Date: 03/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/29/2024
• 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).; NEURON MAX 088 LONG SHEATH (NON-STRYKER).; SYNCHRO 14 GUIDEWIRE (STRYKER).
• Patient Sex: Unknown