MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 3.25MM X 15MM - PMAS; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number	FDS32515
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a neurovascular procedure, the subject flow diverter was advanced in the microcatheter and deployed as usual, but it was noted that the subject flow diverter did not fully open.Therefore, the operator decided to recapture and remove the subject flow diverter.When an attempt was made to recapture the subject flow diverter, it was difficult to recapture the subject flow diverter into the microcatheter.The subject flow diverter along with the microcatheter were taken out of the patient's body.The subject subject flow diverter was replaced and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Additional Manufacturer Narrative
Due to the automated mes system 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 indicated the procedure was completed successfully with another device.The subject device was removed by navigating the intermediate catheter up into the m1 over the microcatheter where the subject stent was partially deployed.The microcatheter and subject stent were then pulled into the intermediate catheter and removed.There was no medical intervention due to the reported event.There was no harm to the patient while removing the device from the patient¿s anatomy.Only the microcatheter used during the procedure was returned.The subject stent was not returned.According to the event description information it was destroyed at the user facility.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 failed/unable to open (when not implanted)¿ and ¿ flow diverter stent difficult/unable to re-capture into microcatheter¿.
Event or Problem Description
It was reported that, during a neurovascular procedure, the subject flow diverter was advanced in the microcatheter and deployed as usual, but it was noted that the subject flow diverter did not fully open.Therefore, the operator decided to recapture and remove the subject flow diverter.When an attempt was made to recapture the subject flow diverter, it was difficult to recapture the subject flow diverter into the microcatheter.The subject flow diverter along with the microcatheter were taken out of the patient's body.The subject subject flow diverter was replaced and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: SURPASS EVOLVE 3.25MM X 15MM - 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: 15855852
• Report Number: 3008881809-2022-00587
• Device Sequence Number: 5117007
• Product Code: OUT
• UDI-Device Identifier: 07613327375152
• UDI-Public: 07613327375152
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 01/06/2023

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: 03/21/2024
• Device Model Number: FDS32515
• Device Catalogue Number: FDS32515
• Device Lot Number: 22810416
• 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: 11/03/2022
• Supplement Date Received by Manufacturer: 12/14/2022
• Initial Report FDA Received Date: 11/23/2022
• Supplement Report FDA Received Date: 01/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2021
• 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 5 INTERMEDIATED CATHETER (STRYKER); EXCELSIOR XT-27 MICROCATHETER (STRYKER)
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Weight: 60 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian