MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.0MM X 20MM - PMAS; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number	FDS40020
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Visual Disturbances (2140); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is implanted in patient.
Event or Problem Description
It was reported that in a clinical trial procedure, the subject flow diverter was used in the left internal carotid artery-ophthalmic (c6 segment) to treat a saccular aneurysm measuring 8.72mm.10 days post procedure, the patient had visual disturbances (blurred vision and vision loss) in the left eye which were treated by administering clopidogrel.The event was reported as recovered/resolved.The event was reported as possibly related to the subject device by the site.
Event or Problem Description
It was reported that in a clinical trial procedure, the subject flow diverter was used in the left internal carotid artery-ophthalmic (c6 segment) to treat a saccular aneurysm measuring 8.72mm.10 days post procedure, the patient had visual disturbances (blurred vision and vision loss) in the left eye which were treated by administering clopidogrel.The event was reported as recovered/resolved.The event was reported as possibly related to the subject device by the site.
Additional Manufacturer Narrative
H4 manufacturing date ¿ added.D4 expiration date - added.Due to the automated manufacturing execution system there are controls in the manufacturing process to ensure the product met specifications upon release.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.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 a saccular aneurysm located in the left internal carotid artery-ophthalmic (c6 segment) measuring 8.72mm.The procedure date for implantation of the stent was (b)(6) 2021 and due to blurred vision in the left eye, clopidogrel 75mg qd was administered on the (b)(6) 2021.The adverse event was resolved.Based upon medical review, the harm observed in this complaint is anticipated in nature as per the device risk assessment.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 that in a clinical trial procedure, the subject flow diverter was used in the left internal carotid artery-ophthalmic (c6 segment) to treat a saccular aneurysm measuring 8.72mm.10 days post procedure, the patient had visual disturbances (blurred vision and vision loss) in the left eye which were treated by administering clopidogrel.The event was reported as recovered/resolved.The event was reported as possibly related to the subject device by the site.
Additional Manufacturer Narrative
B1: adverse event/product problem ¿ corrected - no ¿adverse event¿.B2: outcomes attributed to ae - corrected - no ¿none¿.H1: type of reportable event ¿ corrected - no ¿serious injury¿.H2: if follow-up, type: updated.H10; additional mfg narrative type: updated.The adverse event "visual disturbances (blurred vision and vision loss) in the left eye" was previously reported in mfr report # 3008881809-2022-00007.Upon further review, it was confirmed that the subject device was used on the same event date, in the same case, and on the same patient.The second event of "visual disturbances (blurred vision and vision loss) in the left eye" reported for the same patient is investigated under report mfr report # 3008881809-2021-00254.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 20MM - 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: 13198695
• Report Number: 3008881809-2022-00007
• Device Sequence Number: 17207875
• Product Code: OUT
• UDI-Device Identifier: 07613327375206
• UDI-Public: 07613327375206
• 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
• 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): 10/10/2023

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: 12/01/2023
• Device Model Number: FDS40020
• Device Catalogue Number: FDS40020
• Device Lot Number: 22622681
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/13/2021
• Supplement Date Received by Manufacturer: 03/11/2022; 09/27/2023
• Initial Report FDA Received Date: 01/07/2022
• Supplement Report FDA Received Date: 03/23/2022; 10/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2020
• 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; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 87 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American