MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 5.0MM X 12MM - PMAS; INTRACRANIAL ANEURYSM FLOW DIVERTER

Catalog Number	FDS50012
Medical Device Problem Codes	Activation Failure (3270); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is 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 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.Access was through femoral.The anatomy location/vessel name of intended treatment was internal carotid artery (pcom segment).The position of the delivery catheter was confirmed by visualizing the radiopaque markers throughout the procedure.The position of the flow diverter implant was confirmed between the two marker bands.There was resistance encountered during navigation of the flow diverter device to the target lesion due to very tortuous anatomy.There was a significant amount of resistance throughout procedure.The distal segment did not oppose well and the mid segment would not open and evolve would fall back and not cover the aneurysm neck.The flow diverter recaptured/resheathed back during the procedure 2-3 times and lost access and had to pull the system out and attempt again.There was no stenosis but tortuosity.The evolve did not fully open and did fall back into the more proximal segment.The evolve did migrate proximal when it did not open.After the evolve failed to completely open the physician used a stent to tack down the unopened distal section of the subject device and a second stent to tack down the proximal segment to create a normal lumen and complete the procedure without any complications and the patient was discharged the next day.Both stents were used for the same patient and procedure.The major component of the problem as stated repeatedly is the severe tortuosity in the ica (internal carotid artery) and size being a 5mm artery caused the system to not open completely after deployment.The resistance was throughout the procedure with access and deployment.In the physician¿s opinion, the cause of the flow diverter not to open was significant tortuosity and high riding genu made it very challenging.Based on the information provided, this complaint appears to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural and/or anatomical factors during use.Therefore, an assignable cause of procedural factors will be assigned to the reported ¿stent failed/unable to open¿, ¿stent dislodged/migrated¿, ¿stent friction¿ and ¿stent difficult/unable to advance or pullback through catheter¿.
Event or Problem Description
It was reported that during procedure deployment attempts for two stents.The subject stent failed to open properly due to significant resistance caused by tortuosity and high riding genu.The distal segment of the stent did not oppose well, and the mid-segment failed to open, leading to proximal migration of the stent.To address this, the physician used additional stent to tack down the unopened section of the stent, successfully restoring normal lumen and completing the procedure without complications.The patient was discharged the next day.Resistance was encountered throughout the procedure, primarily due to the severe tortuosity in the ica (internal carotid artery) and the artery size (5mm).

• Brand Name: SURPASS EVOLVE 5.0MM 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: 21138612
• Report Number: 3008881809-2025-00035
• Device Sequence Number: 6807048
• Product Code: OUT
• UDI-Device Identifier: 07613327386707
• UDI-Public: (01)07613327386707(17)241219(10)23362143
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 01/13/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/19/2024
• Device Catalogue Number: FDS50012
• Device Lot Number: 23362143
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/27/2024
• Initial Report FDA Received Date: 01/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/21/2021
• 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: ATLAS STENT (STRYKER); CAT5 CATHETER (STRYKER); INFINITY CATHETER (STRYKER); XT-27 CATHETER (STRYKER)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female