MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.0MM X 12MM - PMAS; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number	FDS40012
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vasoconstriction (2126)
Date of Event	04/13/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device is implanted inside the patient's vasculature.
Event or Problem Description
It was reported in a clinical trial that, the patient was found with incidental vasospasm during procedure for which 100 ug nitroglycerine given and vasospasm promptly resolved and the procedure was completed successfully.The cec (clinical events committee) has assessed the vasospasm to be causally related to the procedure and possibly related to subject flow diverter stent (study device).
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.Based on the information provided in the complaint, the condition being treated was intracranial aneurysm.The subject flow diverter was implanted and the procedure was completed successfully with no device deficiencies reported.An assignable cause of anticipated procedural complication will be assigned to the as reported 'patient vasospasm serious¿ 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 with the directions for use, product labeling and/or risk documentation files.
Event or Problem Description
It was reported in a clinical trial that, the patient was found with incidental vasospasm during procedure for which 100 ug nitroglycerine given and vasospasm promptly resolved and the procedure was completed successfully.The cec (clinical events committee) has assessed the vasospasm to be causally related to the procedure and possibly related to subject flow diverter stent (study device).

• Brand Name: SURPASS EVOLVE 4.0MM X 12MM - 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: 15566892
• Report Number: 3008881809-2022-00497
• Device Sequence Number: 20352931
• Product Code: OUT
• UDI-Device Identifier: 07613327386516
• UDI-Public: 07613327386516
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 12/12/2022

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: 04/26/2024
• Device Model Number: FDS40012
• Device Catalogue Number: FDS40012
• Device Lot Number: 22888004
• 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: 09/12/2022
• Supplement Date Received by Manufacturer: 11/21/2022
• Initial Report FDA Received Date: 10/07/2022
• Supplement Report FDA Received Date: 12/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2021
• 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 INTERMEDIATE CATHETER (STRYKER); EXCELSIOR XT-27 MICROCATHETER (STRYKER)
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 39 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White