MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK 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 Codes	Extravasation (1842); Rupture (2208)
Date of Event	09/13/2023
Type of Reportable Event	Death
Event or Problem Description
Just after deploying the subject flow diverter stent the ica (internal carotid artery) ruptured at the very distal aspect of the stent or immediately distal to subject stent.Extravasation was noted on dsa (digital subtraction angiography).Anesthesia noted an immediate spike in blood pressure just after deployment, a following dsa run showed extravasation.Balloon assisted coiling was used to stop blood flow via ica sacrifice.Patient was put on intraprocedural evd (external ventricular drain).Approximately 2 hours of balloon assisted coiling to sacrifice the ica.Patient expired in the icu (intensive care unit) later that day.
Additional Manufacturer Narrative
H3 other text : the subject device is implanted inside the patient's vasculature.
Event or Problem Description
Just after deploying the subject flow diverter stent the ica (internal carotid artery) ruptured at the very distal aspect of the stent or immediately distal to subject stent.Extravasation was noted on dsa (digital subtraction angiography).Anesthesia noted an immediate spike in blood pressure just after deployment, a following dsa run showed extravasation.Balloon assisted coiling was used to stop blood flow via ica sacrifice.Patient was put on intraprocedural evd (external ventricular drain).Approximately 2 hours of balloon assisted coiling to sacrifice the ica.Patient expired in the icu (intensive care unit) later that day.
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.Additional information provided by the customer did not indicate any issues noted during unpacking or set up of the device, and the device was prepared as per dfu instructions.There was no indication of a user related issue.Other devices used in the procedure in conjunction with the subject device(s): were long sheath, intermediate catheter, deployment microcatheter and a wire.There were no allegations against these devices.The medical procedure the subject device was used for was paraopthalmic intradural aneurysm and the anatomical location of the treatment site was the paraopthalmic/supraclinoid ica (internal carotid artery).The procedure was not completed successfully.The incident was after deployment.Just after deploying surpass the ica ruptured at the very distal aspect of the stent or immediately distal to stent.This issue was noticed during use of the device on the patient.Anaesthesia noted an immediate spike in blood pressure just after deployment, a following dsa run showed extravasation.The procedure was completed with balloon assisted coiling to stop blood flow via ica sacrifice.There was a surgical delay due to this reported event of approximately 2 hours of balloon assisted coiling to sacrifice the ica.A medical intervention was performed due to this event (ica vessel sacrifice via coils and intraprocedural evd - external ventricular drain).The patient expired in the icu (intensive care unit) later that day.Based upon medical review, the harm observed in this complaint is anticipated in nature as per the device risk assessment.An assignable cause of anticipated procedural complication will be assigned to the reported event 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.

• 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: 17887078
• Report Number: 3008881809-2023-00496
• Device Sequence Number: 12506523
• Product Code: OUT
• UDI-Device Identifier: 07613327386530
• UDI-Public: 07613327386530
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 11/02/2023

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: 09/13/2025
• Device Catalogue Number: FDS40017
• Device Lot Number: 23897398
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/14/2023
• Supplement Date Received by Manufacturer: 10/16/2023
• Initial Report FDA Received Date: 10/06/2023
• Supplement Report FDA Received Date: 11/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: INFINITY PLUS CATHETER (STRYKER); SYNCHRO GUIDEWIRE (STRYKER); VECTA 46 CATHETER (STRYKER); XT-27 MICROCATHETER (STRYKER)
• Outcome Attributed to Adverse Event: Death; Required Intervention; Other
• Patient Age: 49 YR
• Patient Sex: Female