MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 5.0MM X 40MM - PMAS; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number	FDS50040
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during the procedure while manipulating the subject stent for treatment site placement, it would not re-capture into the catheter.The physician removed the catheter and the subject stent and the procedure was completed successfully with no clinical consequences to the patient.
Additional Manufacturer Narrative
H4 manufacturing date ¿ added h3 summary attached - updated c2/d10 concomitant products - added d4 expiration date - added 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 device was returned and the lot number was not confirmed as no packaging was returned with the device.During visual inspection the device was returned together with a catheter.The sdw and stent stuck inside the microcatheter.The distal end of the stent delivery wire (sdw) was protruding from the tip of the microcatheter and found to be kinked/bent.The sdw was damaged during attempts to remove it from the microcatheter.The stent was found to be deformed and covered in dried blood.The stent introducer sheath was not returned.During the functional inspection the sdw and stent were stuck inside the microcatheter.The catheter was cut in a few places to remove the sdw and stent.It was not possible to remove the sdw due to damage to the microcatheter and sdw, but the stent was removed.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 was confirmed based on analysis.The device failed to meet specification when received for complaint investigation based on the analyzed anomalies noted to the device.Additional information provided by the customer indicated there was no damage noted to the packaging prior to opening the packaging, the device was confirmed to be in good condition during preparation/prior to use on the patient, the device was prepared for use as per the directions for use and continuous flush was set up and maintained throughout the clinical procedure.The catheter wouldn¿t fully recapture the entirety of the flow diverter stent.The stent was not deployed in the patient and was not fully expanded.A catheter was used to track up over guide catheter and then the whole system was pulled out completely.The stent was re-sheathed 2-3 times during the procedure before placement.It¿s unknown if there was damage to the stent due to the manipulation.The catheter successfully recaptured the majority of the device, but was unable to fully recapture it once it reached the distal marker and lead wire.The procedure was completed successfully and no medical intervention was administered to the patient during the procedure.The patient was not affected as a result of the event.Product analysis found the stent and sdw were returned stuck inside an microcatheter.The distal end of the sdw was protruding from the tip of the microcatheter and found to be kinked/bent.The microcatheter was cut in several sections to remove the sdw and stent.It was not possible to remove the sdw due to damage to the microcatheter shaft and sdw but the stent was removed and found to be deformed and covered in dried blood despite continuous flush being maintained.An assignable cause of procedural factors will be assigned to the reported event of the flow diverter stent difficult/unable to re-capture into microcatheter and the as analyzed event of sdw friction, sdw kinked/bent, stent friction, and stent deformed 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 during the procedure while manipulating the subject stent for treatment site placement, it would not re-capture into the catheter.The physician removed the catheter and the subject stent and the procedure was completed successfully with no clinical consequences to the patient.

• Brand Name: SURPASS EVOLVE 5.0MM X 40MM - 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: 17347346
• Report Number: 3008881809-2023-00357
• Device Sequence Number: 17659612
• Product Code: OUT
• UDI-Device Identifier: 07613327375329
• UDI-Public: 07613327375329
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 08/29/2023

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: 06/25/2025
• Device Model Number: FDS50040
• Device Catalogue Number: FDS50040
• Device Lot Number: 23743067
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/23/2023
• Supplement Date Received by Manufacturer: 08/08/2023
• Initial Report FDA Received Date: 07/18/2023
• Supplement Report FDA Received Date: 08/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: CATALYST 5 CATHETER (STRYKER); EXCELSIOR XT-27 CATHETER (STRYKER); XT-27 CATHETER (STRYKER)
• Patient Sex: Unknown