MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS ELITE FDS 5.0MM X 40MM - PMAS; INTRACRANIAL ANEURYSM FLOW DIVERTER

Catalog Number	FDSE50040
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to the automated manufacturing execution system (mes) there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device is not available; therefore, visual testing as well as functional testing cannot 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 reported that ¿device would not resheath despite multiple attempts with microcatheter.Physician eventually gave up on resheathing and deployed the stent as is.¿ additional information provided by the customer indicated the anatomy was reported to be somewhat tortuous.The device was confirmed to be in good condition after unpacking, no damage or anomalies was noted to the packaging prior to use, the device was confirmed to be in good condition after unpacking, the device prepared as per the dfu, continuous flush was maintained during the procedure, the physician feels that the anatomy and/or location of intended area of treatment may not have contributed to the reported event, a microcatheter was used in conjunction with the subject device.There was no reported resistance encountered during navigation of the flow diverter device to the target lesion, and no resistance during advancement of the stent delivery system through the patient¿s anatomy.The physician was able to deliver the flow diverter device to the target lesion, and there was no reported resistance encountered during the implant (stent) deployment.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 ¿flow diverter stent difficult/unable to re-capture into microcatheter¿.
Event or Problem Description
It was reported that during aneurysm treatment procedure, the subject stent would not resheath despite multiple attempts with microcatheter.Physician eventually gave up on resheathing and deployed the stent.There was no clinical consequence to the patient due to this event.

• Brand Name: SURPASS ELITE FDS 5.0MM X 40MM - 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: 24361529
• Report Number: 3008881809-2026-00092
• Device Sequence Number: 4836700
• Product Code: OUT
• UDI-Device Identifier: 07613327583151
• UDI-Public: (01)07613327583151(17)280304(10)25502731
• 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
• Report Date (Section B): 02/17/2026

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: FDSE50040
• Device Lot Number: 25502731
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 02/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/06/2025
• 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: XT27 MICROCATHETER (STRYKER)
• Patient Sex: Female