MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.0MM X 12MM - PMAS; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number	FDS40012
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2021
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.Visual/microscopic inspection of the subject stent was returned together with an xt-27 microcatheter, and the subject stent was found to be deployed.Additionally, the sdw (stent delivery wire) was found to be kinked/bent as the subject stent was found to be slightly deformed with frayed edges.The introducer sheath was not returned.The xt-27 microcatheter was inspected and no anomaly was noted, it was found to be intact.Functional inspection was unable to perform as the returned subject stent was found to be deployed.The reported complaint was confirmed based on analysis.The subject stent failed to meet specification when received for complaint investigation based on the analyzed anomaly noted to the device.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 that the subject surpass evolve stent device was prepared as per the dfu, the stent delivery system was flushed with saline prior to use.Continuous flush was maintained throughout the procedure, it¿s unknown how torturous was the patient¿s anatomy.While the introducer sheath was seated at the hub, the rhv (rotating hemostatic valve) was opened enough to allow passage of the device through without damage.The introducer sheath was properly inserting all the way into the microcatheter prior to transfer and there was no resistance encountered when advancing the system through the microcatheter during initial advancement, only during re-sheathing.The same microcatheter was not used to complete the procedure, it was switched out for a fresh one.Based on the additional information it appears the physician had no issues advancing the subject stent initially, but issues occurred while attempting to recapture the subject stent back into the microcatheter during deployment in the patient.Product analysis found the subject stent had been deployed from the surpass evolve flow diverter system.This indicates the subject stent had been deployed too far out of the microcatheter to allow the stent to be re-captured, i.E.The resheath marker had been advanced beyond the microcatheter marker band, which is effectively a full deployment and the re-sheath pad is no longer effective at this point, and re-capture is not possible.An xt-27 microcatheter was returned with the fds (flow diverter system).The xt-27 microcatheter was inspected and no anomaly was noted.The subject stent was slightly deformed with frayed edges and the sdw was kinked at the distal end.The introducer was not returned for analysis.An assignable cause of procedural factors will be assigned to as reported and the as analyzed 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
The subject device was returned for analysis and discovered that the subject stent was deployed prematurely during use.There were no clinical consequences to the patient reported as a result of this event.

• Brand Name: SURPASS EVOLVE 4.0MM 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: 13423985
• Report Number: 3008881809-2022-00046
• Device Sequence Number: 5304237
• Product Code: OUT
• UDI-Device Identifier: 07613327386516
• UDI-Public: 07613327386516
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 02/02/2022

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: 11/08/2023
• Device Model Number: FDS40012
• Device Catalogue Number: FDS40012
• Device Lot Number: 22576179
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2022
• Initial Report FDA Received Date: 02/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2020
• 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 Sex: Unknown