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); Stenosis (2263)
Date of Event	05/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that in the clinical trial the subject flow diverter stent was implanted in a patient on (b)(6) 2021 to treat intracranial aneurysm in the left internal carotid artery-communicating (c7 segment) and the procedure was completed successfully.Six months post procedure the follow-up lab findings noted that the patient had 50-75% in-stent stenosis within the subject flow diverter stent.There are no aes reported by the site.No additional information is available.
Additional Manufacturer Narrative
The device is not available to the manufacturer as the subject device was 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.It was reported that patient has 50-75% in-stent stenosis within the subject flow diverter at the 6mo timepoint based on core lab reviewer #1.It was also reported that there are no adverse events reported by the site for this subject and the stenosis is a core lab finding only.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 as reported 'patient parent vessel stenosis' for this complaint.
Event or Problem Description
It was reported that in the clinical trial the subject flow diverter stent was implanted in a patient on (b)(6) 2021 to treat intracranial aneurysm in the left internal carotid artery-communicating (c7 segment) and the procedure was completed successfully.Six months post procedure the follow-up lab findings noted that the patient had 50-75% in-stent stenosis within the subject flow diverter stent.There are no aes reported by the site.No additional information is available.
Event or Problem Description
It was reported that in the clinical trial the subject flow diverter stent was implanted in a patient on (b)(6) 2021 to treat intracranial aneurysm in the left internal carotid artery-communicating (c7 segment) and the procedure was completed successfully.Six months post procedure the follow-up lab findings noted that the patient had 50-75% in-stent stenosis within the subject flow diverter stent.There are no aes reported by the site.No additional information is available.Update: additional information received on 15-nov-2023 stated that the patient complained of (ae2) severe headache.10/10 headache with nausea and vomiting.Took advil, zofran and zolpidem without relief.Iv- reglan, benadryl.Ae2 stared on (b)(6) 2023 and stopped on (b)(6) 2023 with outcome of recovered/resolved.Patient was given ibuprofen - otc tablet- as needed-oral, metoclopramide-10 mg-bid- twice a day - i/v, diphenhydramine-25 mg-once-i/v, sodium chloride 1000ml-once i/v.This ae is not related to the study procedure, dapt, other stryker devices, disease under study and possibly related to the study device and underlying condition or disease.No other information was available.
Additional Manufacturer Narrative
B5 - executive summary - updated.H6 clinical signs code grid - updated.H6 health impact code grid - 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 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 patient has 50-75% in-stent stenosis within the subject flow diverter at the 6mo timepoint based on core lab reviewer #1.It was also reported that there are no aes reported by the site for this subject and the stenosis is a core lab finding only.Additional information received on 15nov2023: 10/10 headache with nausea and vomiting.Took advil, zofran and zolpidem without relief.Iv- reglan, benadryl.Ct head, cta head and mri done.Concomitant /additional treatment given.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.

• 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: 14541101
• Report Number: 3008881809-2022-00253
• Device Sequence Number: 20126655
• Product Code: OUT
• UDI-Device Identifier: 07613327386530
• UDI-Public: 07613327386530
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 12/07/2023

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: 09/14/2023
• Device Model Number: FDS40017
• Device Catalogue Number: FDS40017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/02/2022
• Supplement Date Received by Manufacturer: 07/25/2022; 11/15/2023
• Initial Report FDA Received Date: 05/30/2022
• Supplement Report FDA Received Date: 08/18/2022; 12/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2020
• 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: 59 YR
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White