MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.5MM X 20MM - PMAS; INTRACRANIAL ANEURYSM FLOW DIVERTER

Catalog Number	FDS45020
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	08/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the subject flow diverter performed as intended during the procedure and implantation at fusiform distal ica (internal carotid artery) aneurysm.During a follow-up diagnostic appointment , mal apprehension (narrowed and not apposed) was observed in the subject's proximal stent.90% fish-mouthing was observed on the proximal end of the subject stent during the follow-up not caused by hyperplasia or thrombosis.No additional information is available.
Event or Problem Description
It was reported that the subject flow diverter performed as intended during the procedure and implantation at fusiform distal ica (internal carotid artery) aneurysm.During a follow-up diagnostic appointment, mal apprehension (narrowed and not apposed) was observed in the subject's proximal stent.90% fish-mouthing was observed on the proximal end of the subject stent during the follow-up not caused by hyperplasia or thrombosis.No additional information is available.
Additional Manufacturer Narrative
Date of implant - d6a - added.Suspect medical device - gtin - d4 - corrected from '(b)(4)'.Pma/510(k) - g4 - corrected from 'p170024/s003' to 'p170024'.Due to the automated mes (manufacturing execution system) system there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not 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 stated that ' during a diagnostic appointment when the patient came back, it was noticed that there was mal apprehension on proximal stent'.No surgical delay and no medical intervention were reported.There was an adverse consequence to the patient, ¿90% fish-mouthing was observed on the proximal end of the stent during the follow-up¿.The patient was discharged home.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 the as reported 'patient parent vessel stenosis¿.

• Brand Name: SURPASS EVOLVE 4.5MM X 20MM - 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: 20189875
• Report Number: 3008881809-2024-00415
• Device Sequence Number: 15218554
• Product Code: OUT
• UDI-Device Identifier: 07613327375251
• UDI-Public: (01)07613327375251(17)250625(10)23743056
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P170024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2024

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: 06/25/2025
• Device Catalogue Number: FDS45020
• Device Lot Number: 23743056
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/21/2024
• Supplement Date Received by Manufacturer: 09/20/2024
• Initial Report FDA Received Date: 09/11/2024
• Supplement Report FDA Received Date: 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown