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	Nausea (1970)
Date of Event	12/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is implanted in patient.
Event or Problem Description
It was reported in a clinical trial procedure to treat a saccular intracranial aneurysm measuring 9.2mm in the left internal carotid artery-ophthalmic (c6 segment), that the patient had a headache after the procedure and intermittently since the procedure.The headache was accompanied by nausea.No diagnostic tests, treatment, interventional procedures or hospitalizations were performed in response to the headache.Headache is reported as recovering/resolving.According to the site, the reported event was possibly related to the subject flow diverter.No other information is available.
Event or Problem Description
It was reported in a clinical trial procedure to treat a saccular intracranial aneurysm measuring 9.2mm in the left internal carotid artery-ophthalmic (c6 segment), that the patient had a headache after the procedure and intermittently since the procedure.The headache was accompanied by nausea.No diagnostic tests, treatment, interventional procedures or hospitalizations were performed in response to the headache.Headache is reported as recovering/resolving.According to the site, the reported event was possibly related to the subject flow diverter.No other information is available.
Additional Manufacturer Narrative
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.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.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 the patient 'had headache after procedure and intermittently since the procedure.Sometimes with nausea due to headaches.The implanted device covered the ophthalmic artery'.Headache is associated with covid.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: 13256813
• Report Number: 3008881809-2022-00012
• Device Sequence Number: 1548232
• Product Code: OUT
• UDI-Device Identifier: 07613327375190
• UDI-Public: 07613327375190
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 03/23/2022

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: 12/14/2023
• Device Model Number: FDS40015
• Device Catalogue Number: FDS40015
• Device Lot Number: 22643761
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/20/2021
• Supplement Date Received by Manufacturer: 03/11/2022
• Initial Report FDA Received Date: 01/13/2022
• Supplement Report FDA Received Date: 03/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: EXCELSIOR XT-27 (STRYKER).; SYNCHRO GUIDEWIRE (STRYKER).
• Outcome Attributed to Adverse Event: Other
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 52 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American