MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 5.0MM X 20MM - PMAS; INTRACRANIAL ANEURYSM FLOW DIVERTER

Catalog Number	FDS50020
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, after the third re-sheath the subject stent came off the re-sheath pad prematurely.The physician deployed the subject stent in the microcatheter before removing both devices from the patient.No clinical consequences were reported to the patient due to this event.
Event or Problem Description
It was reported that during the procedure, after the third re-sheath the subject stent came off the re-sheath pad prematurely.The physician deployed the subject stent in the microcatheter before removing both devices from the patient.No clinical consequences were reported to the patient due to this event.
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, functional testing as well as visual 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.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.After the third resheath the stent had moved from the resheath pad so the physician deployed it in the microcatheter before pulling out both the stent delivery wire and microcatheter.The stent deployed inside of the microcatheter.The microcatheter was inside of the patient.Both the stent and microcatheter were pulled out.The position of the flow diverter implant was confirmed between the two marker bands.There was no resistance encountered during navigation of the flow diverter device to the target lesion.The physician was able to deliver the flow diverter device to the target lesion.The flow diverter was recaptured back into the microcatheter and this happened on the third time.The patient¿s anatomy was very tortuous, high riding posterior genu.In the physician¿s opinion, the cause of the reported issue was a combination of the patients vessel tortuosity and an issue with this specific stent (second one we used of the same size deployed perfectly the first time with no issues).There was no adverse event, according to the physician, the event was related to the stent.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 'stent deployed prematurely during use¿.

• Brand Name: SURPASS EVOLVE 5.0MM X 20MM - 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: 20844931
• Report Number: 3008881809-2024-00571
• Device Sequence Number: 7942245
• Product Code: OUT
• UDI-Device Identifier: 07613327375299
• UDI-Public: (01)07613327375299(17)250625(10)23743061
• 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): 02/07/2025

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 Expiration Date: 06/25/2025
• Device Catalogue Number: FDS50020
• Device Lot Number: 23743061
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/18/2024
• Supplement Date Received by Manufacturer: 01/16/2025
• Initial Report FDA Received Date: 12/04/2024
• Supplement Report FDA Received Date: 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/27/2022
• 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: XT-27 MICROCATHETER (STRYKER)
• Patient Age: 76 YR
• Patient Sex: Female