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	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, the subject stent encountered friction when attempting to re-sheath with microcatheter.Physician was not able to re-sheath.The procedure was completed successfully with no clinical consequences to the patient.
Additional Manufacturer Narrative
D9.- returned to manufacturer on - updated.H3.- device evaluated by mfg ¿ updated.Due to the automated manufacturing execution system (mes) there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection the stent delivery wire (sdw) was returned with a microcatheter.The stent was returned deployed.The stent was deformed.The proximal and distal ends of the stent had frayed braid edges.The proximal and distal sdw was kinked/bent.The microcatheter was inspected and found to be kinked/bent.The introducer sheath was not returned.During functional inspection for ¿flow diverter stent difficult/unable to re-capture into microcatheter¿ was not able to be performed as the stent was returned having been deployed.The sdw was removed from the microcatheter without issue.The microcatheter was flushed, and a 0.027" pin gauge was inserted into the hub without difficulties, it met the proximal end of the catheter shaft when inserted into the microcatheter hub.The distal microcatheter was noted to be wrinkled.The microcatheter was flushed and a 0.0265" patency mandrel was advanced through the microcatheter shaft with slight friction felt was felt towards the distal end where the catheter shaft was damaged.The reported event ¿flow diverter stent difficult/unable to re-capture into microcatheter¿ could not be duplicated; however, the analysis results are consistent with the reported event.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 physician reported the 'stent encountered friction when attempting to re-sheath with the microcatheter.The physician was not able to re-sheath.This was the first attempt at re-sheath'.Additional information provided by the customer did not indicate any issues noted during unpacking or set up of the device, and the device was prepared as per dfu instructions.There was no indication of a user related issue.The patient¿s anatomy was moderately tortuous.Doctor deployed the subject stent on the back table to inspect when removed from microcatheter.Product analysis found the sdw was returned with a microcatheter.The stent was returned deployed as per additional information and was notably deformed.The proximal and distal ends of the stent had frayed braid edges.The proximal and distal sdw was kinked/bent.The microcatheter was inspected and found to be kinked/bent.The introducer sheath was not returned.The damage noted to the returned device indicates that a significant force was applied during advancing or adjusting the stent in the microcatheter, most likely inside the microcatheter which caused the sdw and microcatheter to kink/bend.The related microcatheter device was found to be damaged with ripples/kinks consistent with force being applied.The anatomy was reported to be moderately tortuous which may have contributed to the reported event.An assignable cause of procedural factors will be assigned to the reported event ¿flow diverter stent difficult/unable to re-capture into microcatheter¿ and to the analyzed event ¿stent deformed¿ and 'sdw kinked/bent' as the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.
Event or Problem Description
It was reported that during the procedure, the subject stent encountered friction when attempting to re-sheath with microcatheter.Physician was not able to re-sheath.The procedure was completed successfully with no clinical consequences to the patient.

• 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: 23843249
• Report Number: 3008881809-2025-00737
• Device Sequence Number: 15845941
• Product Code: OUT
• UDI-Device Identifier: 07613327582598
• UDI-Public: (01)07613327582598(17)280304(10)2550273
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 03/09/2026

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: FDSE32512
• Device Lot Number: 25502735
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/01/2025
• Supplement Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Unknown