MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.0MM X 15MM - PMAS; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number	FDS40015
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	11/30/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that 270 days post implant with the subject flow diverter in a clinical trial procedure to treat an unruptured saccular intracranial aneurysm measuring 4.5mm in the right internal carotid artery-ophthalmic (c6 segment), the patient had in stent stenosis that had increased from 0-25% post implantation to 50-75% at 6 months follow up.During the procedure, the subject flow diverter was reported to have been opened and used successfully to completely cover the aneurysm neck.No treatment was administered for the reported event.The patient did not experience any clinical complications since the last visit.No other information is available.
Additional Manufacturer Narrative
Device is implanted in patient.
Event or Problem Description
It was reported that 270 days post implant with the subject flow diverter in a clinical trial procedure to treat an unruptured saccular intracranial aneurysm measuring 4.5mm in the right internal carotid artery-ophthalmic (c6 segment), the patient had in stent stenosis that had increased from 0-25% post implantation to 50-75% at 6 months follow up.During the procedure, the subject flow diverter was reported to have been opened and used successfully to completely cover the aneurysm neck.No treatment was administered for the reported event.The patient did not experience any clinical complications since the last visit.No other information is available.
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 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.It was reported that 6 months after a clinical trial procedure with the subject flow diverter, the patient had post implantation in-stent stenosis that increased to 50-75%.Additional information provided by the customer indicated that the device was successfully implanted without any device deficiencies, the post implantation in-stent stenosis was 0-25%, the subject did not experience any new adverse events or changes to existing adverse events since the last visit, unruptured saccular intracranial aneurysm measuring 4.5mm was being treated with the subject device, and the event occurred in the right internal carotid artery-ophthalmic (c6 segment).Based upon medical review, the harm observed in this complaint is anticipated in nature as per the device risk assessment.As a product related root cause does not apply and the issue is due to a known physiological effect of the procedure and/or patient condition noted within the dfu, product labeling and/or risk documentation files, an assignable cause of anticipated procedural complication will be assigned to this complaint.

• Brand Name: SURPASS EVOLVE 4.0MM 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: 13056378
• Report Number: 3008881809-2021-00540
• Device Sequence Number: 17115644
• Product Code: OUT
• UDI-Device Identifier: 07613327375190
• UDI-Public: 07613327375190
• 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
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/09/2023
• Device Model Number: FDS40015
• Device Catalogue Number: FDS40015
• Device Lot Number: 22451793
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/30/2021
• Supplement Date Received by Manufacturer: 02/25/2022
• Initial Report FDA Received Date: 12/21/2021
• Supplement Report FDA Received Date: 03/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2020
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 44 YR
• Patient Sex: Female
• Patient Weight: 60 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White