MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.5MM X 12MM - PMAS; INTRACRANIAL ANEURYSM FLOW DIVERTER

Catalog Number	FDS45012
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	10/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that post with subject flow diverter stent on 2 years follow up visit patient complains of having several intermittent episodes of left eye lower visual field go "black" and then resolve about 30 seconds since (b)(6) 2022.Plavix medication was resumed.Ophthalmology consult submitted to assess eye, flow and rule out emboli.The adverse event was indicated to be possibly related to the study device, dapt (dual antiplatelet therapy) and an underlying condition or disease.The adverse event outcome is indicated as not recovered/not resolved.
Additional Manufacturer Narrative
H3 other text : the subject device is implanted inside the patient's vasculature.
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 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.Additional information provided by the customer indicated the total procedure time was 29 min.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 post with subject flow diverter stent on 2 years follow up visit patient complains of having several intermittent episodes of left eye lower visual field go "black" and then resolve about 30 seconds since (b)(6) 2022.Plavix medication was resumed.Ophthalmology consult submitted to assess eye, flow and rule out emboli.The adverse event was indicated to be possibly related to the study device, dapt (dual antiplatelet therapy) and an underlying condition or disease.The adverse event outcome is indicated as not recovered/not resolved.
Event or Problem Description
It was reported that post with subject flow diverter stent on 2 years follow up visit patient complains of having several intermittent episodes of left eye lower visual field go "black" and then resolve about 30 seconds since (b)(6) 2022.Plavix medication was resumed.Ophthalmology consult submitted to assess eye, flow and rule out emboli.The adverse event was indicated to be possibly related to the study device, dapt (dual antiplatelet therapy) and an underlying condition or disease.The adverse event outcome is indicated as not recovered/not resolved.Additional information received on 2- may-2024 reported that as per independent medical review (imr), intermittent left eye lower vision loss is not related to the study device.
Additional Manufacturer Narrative
B1: adverse event/product problem ¿ corrected - no ¿adverse event¿.B2: outcomes attributed to ae - corrected - "none".H1: type of reportable event ¿ corrected - no ¿serious injury'.F10 / h6 medical device problem code - corrected.F10/ h6 investigation conclusions - corrected.F10 / h6 clinical sign code - corrected.F10 / h6 health impact code - corrected.Due to the automated mes (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.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.Additional information provided by the customer indicated the total procedure time was 29 min.Additional information received on 2- may-2024 states ¿per independent medical review (imr), the adverse event (ae) intermittent left eye lower vision loss is not related to the study device.Ae outcome was reported as recovered/resolved¿.While there are a number of potential causes for the reported issue, because the reported issue is unknown/unclear and the device was not returned, an assignable cause of undeterminable will be assigned to as reported "device within specifications".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 4.5MM X 12MM - 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: 17580364
• Report Number: 3008881809-2023-00426
• Device Sequence Number: 8877748
• Product Code: OUT
• UDI-Device Identifier: 07613327386592
• UDI-Public: 07613327386592
• Combination Product (Y/N): N
• 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): 05/22/2024

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: 08/30/2023
• Device Catalogue Number: FDS45012
• Device Lot Number: 22422898
• 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: 07/27/2023
• Supplement Date Received by Manufacturer: 09/12/2023; 05/02/2024
• Initial Report FDA Received Date: 08/18/2023
• Supplement Report FDA Received Date: 10/04/2023; 05/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2020
• 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: 54 YR
• Patient Sex: Male