MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.0MM X 17MM - PMAS; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number	FDS40017
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a neurovascular surgical procedure was performed in a patient with cavernous aneurysm.During the procedure the physician felt resistance while advancing the subject flow diverter to the target lesion.At the target lesion the physician felt the subject flow diverter didn¿t feel as smooth as usual and didn¿t want to force it to open, therefore the physician attempted to re-sheath the subject flow diverter but increased resistance was felt when the subject flow diverter was re-sheathed.The subject flow diverter along with the microcatheter were removed from the patients vasculature.The subject flow diverter and the microcatheter were 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.
Event or Problem Description
It was reported that a neurovascular surgical procedure was performed in a patient with cavernous aneurysm.During the procedure the physician felt resistance while advancing the subject flow diverter to the target lesion.At the target lesion the physician felt the subject flow diverter didn¿t feel as smooth as usual and didn¿t want to force it to open, therefore the physician attempted to re-sheath the subject flow diverter but increased resistance was felt when the subject flow diverter was re-sheathed.The subject flow diverter along with the microcatheter were removed from the patients vasculature.The subject flow diverter and the microcatheter were replaced and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
D4 expiration date - added.H4 manufacturing date ¿ added.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 that the device may not have been prepped correctly.After the case it was questioned if the tech had prepped the device properly.Further details were not provided.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 and the device was not returned, an assignable cause of undeterminable was assigned to the as reported 'flow diverter stent difficult/unable to capture into micro-catheter', 'stent difficult/unable to advance or pullback through catheter' for this complaint.

• Brand Name: SURPASS EVOLVE 4.0MM 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: 14114587
• Report Number: 3008881809-2022-00178
• Device Sequence Number: 13983859
• Product Code: OUT
• UDI-Device Identifier: 07613327386530
• UDI-Public: 07613327386530
• 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,Followup
• Report Date (Section B): 07/26/2022

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: 05/19/2024
• Device Model Number: FDS40017
• Device Catalogue Number: FDS40017
• Device Lot Number: 22939063
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/22/2022
• Supplement Date Received by Manufacturer: 06/30/2022
• Initial Report FDA Received Date: 04/14/2022
• Supplement Report FDA Received Date: 07/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2021
• 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: CATALYST 5 CATHETER (STRYKER); EXCELSIOR XT-27 MICROCATHETER (STRYKER)
• Patient Sex: Female