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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Headache (1880); Visual Impairment (2138)
Date of Event	12/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is implanted in patient.
Event or Problem Description
It was reported after a successful clinical trial procedure in the left internal carotid artery-clinoid (c5 segment) to treat a fusiform intracranial aneurysm measuring 6.2mm, the patient had a minimal transient headache on the same day.No diagnostic tests, intervention, treatment or hospitalization were done due to headache and it was reported as recovering/resolving.The patient also had vision impairment, 1 day post procedure.This presented as morning visual changes in the left eye and seeing shadows when looking at letters but not images.No diagnostic tests, intervention, treatment or hospitalization were done due to the vision changes and it was reported as recovering/resolving.The site reported the headache as probably related and the visual impairment as causally related to the subject flow diverter.
Event or Problem Description
It was reported after a successful clinical trial procedure in the left internal carotid artery-clinoid (c5 segment) to treat a fusiform intracranial aneurysm measuring 6.2mm, the patient had a minimal transient headache on the same day.No diagnostic tests, intervention, treatment or hospitalization were done due to headache and it was reported as recovering/resolving.The patient also had vision impairment, 1 day post procedure.This presented as morning visual changes in the left eye and seeing shadows when looking at letters but not images.No diagnostic tests, intervention, treatment or hospitalization were done due to the vision changes and it was reported as recovering/resolving.The site reported the headache as probably related and the visual impairment as causally related to the subject flow diverter.
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 manufacturing execution 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 suffered minimal transient headache.Post stent headache.The implanted stent covered the ophthalmic artery, and some vision impairment was noted.Vision change on left eye, seeing "shadows" when looking at letters but not images.Started in the morning.No change to vision in right eye.Issue is resolving.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.
Event or Problem Description
It was reported after a successful clinical trial procedure in the left internal carotid artery-clinoid (c5 segment) to treat a fusiform intracranial aneurysm measuring 6.2mm, the patient had a minimal transient headache on the same day.No diagnostic tests, intervention, treatment or hospitalization were done due to headache and it was reported as recovering/resolving.The patient also had vision impairment, 1 day post procedure.This presented as morning visual changes in the left eye and seeing shadows when looking at letters but not images.No diagnostic tests, intervention, treatment or hospitalization were done due to the vision changes and it was reported as recovering/resolving.The site reported the headache as probably related and the visual impairment as causally related to the subject flow diverter.Information received on 11-apr-2022 confirms that the imr (designated cec member) has assessed the post procedural 'headache' in the patient as possibly related to the study device and imr (designated cec member) has assessed the post procedural 'vision impairment' in the patient as not related to the study device.
Additional Manufacturer Narrative
F10 / h6 health effect - clinical code - corrected (visual impairment - removed and headache - 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.It was reported that the patient suffered minimal transient headache.Post stent headache.The implanted stent covered the ophthalmic artery, and some vision impairment was noted.Vision change on left eye, seeing "shadows" when lookin at letters but not images.Started in the morning.No change to vision in right eye.Issue is resolving.Additional information received on 11-apr-2022; the imr (designated cec member) has assessed ' headache' as possibly related to the study device and the imr (designated cec member) has assessed 'vision impairment' as not related to the study device".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 headache non-serious' in this complaint.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.

• 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: 13260426
• Report Number: 3008881809-2022-00014
• Device Sequence Number: 16539167
• Product Code: OUT
• UDI-Device Identifier: 07613327386530
• UDI-Public: 07613327386530
• 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,Followup
• Report Date (Section B): 06/06/2022

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: 10/08/2023
• Device Model Number: FDS40017
• Device Catalogue Number: FDS40017
• Device Lot Number: 22517706
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/22/2021
• Supplement Date Received by Manufacturer: 03/14/2022; 05/10/2022
• Initial Report FDA Received Date: 01/14/2022
• Supplement Report FDA Received Date: 03/23/2022; 06/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2020
• 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: 62 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian