MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.5MM X 17MM - PMAS; INTRACRANIAL ANEURYSM FLOW DIVERTER

Catalog Number	FDS45017
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	01/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3 other text : device is implanted in the patient.
Event or Problem Description
It was reported that the subject flow diverter was implanted in a patient successfully with no device deficiency on 2023 to treat saccular aneurysm at left internal carotid artery-ophthalmic (c6 segment).The patient called on (b)(6) 2024 to report 4 days of repeat episodes of left eye vision loss that appears like a bright white light that is obstructing vision since (b)(6) 2024.The patient was put off plavix after 6 month visit on (b)(6) 2024.Re-started plavix (b)(6) 2024.As of update on (b)(6) 2024 since re starting dapt, patient has had 3 episodes of this left eye vision loss in the last month, which is improved from 3 a day as compared to when she was only on asa (acetylsalicylic acid).Cta (computed tomography angiography) head performed on (b)(6) 2024 shows widely patent subject flow diverter stent and indicates no acute intracranial hemorrhage, mass effect or acute territorial infraction.No large vessel occlusion or hemodynamically significant stenosis in the major intracranial arteries.No clear explanation for ae (adverse event).Eye exam scheduled for (b)(6) 2024.The ae outcome is indicated as not recovered/not resolved.It is reported that the ae is probably related to study procedure and study device.Rationale for relationship to the study device or study procedure is indicated as "possibly the flow diverter is impeding the flow to the ophthalmic artery".
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.There was medical intervention and an adverse consequence reported ¿the patient called on (b)(6) 2024 to report 4 days of repeat episodes of left eye vision loss that appears like a bright white light that is obstructing vision since (b)(6) 2024.The patient was put off plavix after 6 month visit on (b)(6) 2024.Re-started plavix (b)(6) 2024.As of update on (b)(6) 2024 since re starting dapt, patient has had 3 episodes of this left eye vision loss in the last month, which is improved from 3 a day as compared to when she was only on asa (acetylsalicylic acid).Cta (computed tomography angiography) head performed on (b)(6) 2024 shows widely patent subject flow diverter stent.No clear explanation for ae (adverse event).Eye exam scheduled for (b)(6) 2024.".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 in a patient successfully with no device deficiency on (b)(6) 2023 to treat saccular aneurysm at left internal carotid artery-ophthalmic (c6 segment).The patient called on (b)(6) 2024 to report 4 days of repeat episodes of left eye vision loss that appears like a bright white light that is obstructing vision since (b)(6) 2024.The patient was put off plavix after 6 month visit on (b)(6) 2024.Re-started plavix (b)(6) 2024.As of update on (b)(6) 2024 since re starting dapt, patient has had 3 episodes of this left eye vision loss in the last month, which is improved from 3 a day as compared to when she was only on asa (acetylsalicylic acid).Cta (computed tomography angiography) head performed on (b)(6) 2024 shows widely patent subject flow diverter stent and indicates no acute intracranial hemorrhage, mass effect or acute territorial infraction.No large vessel occlusion or hemodynamically significant stenosis in the major intracranial arteries.No clear explanation for ae (adverse event).Eye exam scheduled for (b)(6) 2024.The ae outcome is indicated as not recovered/not resolved.It is reported that the ae is probably related to study procedure and study device.Rationale for relationship to the study device or study procedure is indicated as "possibly the flow diverter is impeding the flow to the ophthalmic artery".

• Brand Name: SURPASS EVOLVE 4.5MM 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: 19055961
• Report Number: 3008881809-2024-00153
• Device Sequence Number: 15201708
• Product Code: OUT
• UDI-Device Identifier: 07613327386639
• UDI-Public: 07613327386639
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P170024/S003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2024

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: 08/26/2023
• Device Catalogue Number: FDS45017
• Device Lot Number: 22413075
• 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: 03/25/2024
• Supplement Date Received by Manufacturer: 04/23/2024
• Initial Report FDA Received Date: 04/05/2024
• Supplement Report FDA Received Date: 05/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2020
• 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: Required Intervention; Other
• Patient Age: 53 YR
• Patient Sex: Female