MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.5MM X 17MM - PMAS; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number	FDS45017
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to the automated manufacturing execution system (mes) system there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device is not available; therefore, visual and functional testing as well as physical analysis cannot be performed.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.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.Additional information provided by the customer indicated the device was confirmed to be in good condition prior to use, preparation/set-up was performed as per the directions for use and continuous flush was maintained for the duration of the procedure.No excessive force was applied at any point while advancing the stent within the microcatheter.The outer diameter of the guidewire used was 14, the id of the guide catheter used was 058.The delivery catheter and pusher were purged with sterile saline and it was verified that fluid exited the end of the delivery catheter and pusher.The position of the delivery catheter was confirmed by visualizing the radiopaque markers and the position of the flow diverter implant was confirmed between the two marker bands.There was no resistance between the delivery catheter and the pusher, there was no resistance encountered during navigation of the flow diverter device to the target lesion, there was no resistance encountered during the flow diverter deployment and there was no resistance during advancement of the flow diverter delivery system through the patient¿s anatomy.The anatomy was not tortuous.The procedure was completed successfully with use of another flow diverter device.There was no impact to the patient as a result of the event.The size of the stent was appropriate for the treatment site.The condition being was aneurysm, the anatomical location of the treatment site was the ica.The physician alleges there was a malfunction of a device for this procedure.There was not a high % stenosis proximal to the flow diverter likely contributing to the inability to deploy the flow diverter.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 of stent failed/unable to open.
Event or Problem Description
It was reported that during the ica aneurysm procedure, the stent (subject device) failed to open in the middle portion.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.

• Brand Name: SURPASS EVOLVE 4.5MM 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: 17127378
• Report Number: 3008881809-2023-00301
• Device Sequence Number: 17986175
• Product Code: OUT
• UDI-Device Identifier: 07613327386639
• UDI-Public: 07613327386639
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P170024/S003
• 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): 06/14/2023

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: 10/18/2024
• Device Model Number: FDS45017
• Device Catalogue Number: FDS45017
• Device Lot Number: 23265862
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/17/2023
• Initial Report FDA Received Date: 06/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2021
• 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: AXS CATALYST CATHETER (STRYKER); XT-27 MICROCATHETER (STRYKER)
• Patient Sex: Unknown