MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK - MHRA ORG ID:31806 SURPASS EVOLVE 4.0MM X 17MM - PMAS; INTRACRANIAL ANEURYSM FLOW DIVERTER

Catalog Number	FDS40017
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Disturbances (2140)
Date of Event	06/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3 other text : the subject device is implanted inside the patient's vasculature.
Event or Problem Description
It was reported that the subject flow diverter was implanted successfully in a patient on (b)(6) 2022.Post procedure sometime in (b)(6) 2023 patient experienced intermittent vision loss of right eye.It was reported that transient visual loss right eye resolved/recovered without any treatment sometime in (b)(6) 2023.It is indicated that the transient visual loss right eye is possibly relate to the study device.The patient has a past medical history of severe headache/migraine, depression/anxiety, dyslipidemia, obesity, essential tremor, vertigo, etc.It is indicated that the transient visual loss right eye was classified as non-serious adverse event.
Additional Manufacturer Narrative
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 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 upon medical review, the harm observed in the complaint is anticipated in nature as per the device risk assessment and does not require escalation to senior management.An assignable cause of anticipated procedural complication will be assigned to the reported ¿patient neurological deficit¿ 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 that the subject flow diverter was implanted successfully in a patient on (b)(6) 2022.Post procedure sometime in (b)(6) 2023 patient experienced intermittent vision loss of right eye.It was reported that transient visual loss right eye resolved/recovered without any treatment sometime in (b)(6) 2023.It is indicated that the transient visual loss right eye is possibly relate to the study device.The patient has a past medical history of severe headache/migraine, depression/anxiety, dyslipidemia, obesity, essential tremor, vertigo, etc.It is indicated that the transient visual loss right eye was classified as non-serious adverse event.
Additional Manufacturer Narrative
B5 executive summary - updated.D4 gtin - updated.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 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.An assignable cause of anticipated procedural complication will be assigned to the reported event ¿patient neurological deficit¿ 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 that the subject flow diverter was implanted successfully in a patient on (b)(6) 2022.Post procedure sometime in (b)(6) 2023 patient experienced intermittent vision loss of right eye.It was reported that transient visual loss right eye resolved/recovered without any treatment sometime in (b)(6) 2023.It is indicated that the transient visual loss right eye is possibly relate to the study device.The patient has a past medical history of severe headache/migraine, depression/anxiety, dyslipidemia, obesity, essential tremor, vertigo, etc.It is indicated that the transient visual loss right eye was classified as non-serious adverse event.Update: received information about adverse event (b)(6) on (b)(6) 2024.The patient reported to experience transient visual loss right eye on (b)(6) 2024.The adverse event recovered/resolved on its own without any treatment on (b)(6) 2024.It is indicated that the transient visual loss right eye is possibly relate to the study device.Transient visual loss right eye was classified as non-serious adverse event.

• Brand Name: SURPASS EVOLVE 4.0MM X 17MM - PMAS
• Common Device Name: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK - MHRA ORG ID:31806; 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: 18016658
• Report Number: 3008881809-2023-00520
• Device Sequence Number: 6537677
• Product Code: OUT
• UDI-Device Identifier: 07613327386530
• UDI-Public: (01)07613327386530(17)240609(10)22964264
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Followup
• Report Date (Section B): 10/21/2024

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: 06/09/2024
• Device Catalogue Number: FDS40017
• Device Lot Number: 22964264
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 11/08/2023; 09/30/2024
• Initial Report FDA Received Date: 10/26/2023
• Supplement Report FDA Received Date: 11/16/2023; 10/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 45 YR
• Patient Sex: Female