MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 5.0MM X 40MM - PMAS; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number	FDS50040
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Visual Impairment (2138); Thrombosis/Thrombus (4440)
Date of Event	09/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device remained implanted.
Event or Problem Description
It was reported that the patient had experienced acute central retinal artery thrombosis approximately 32 hours post deployment of the subject flow diverter.The patient experienced acute loss of vision in ipsilateral eye of implantation.The subject flow diverter was implanted in the cavernous segment of the internal carotid artery (ica) and no difficulties were encountered during the procedure.Patient received 6mg of ia tpa in carotid and external artery as a medical intervention to treat the thrombosis and loss of vision.The vision improved after the patent received the medication.16 hours post tpa patient¿s scan showed many microhemorrhages and medical management was used to following indication of hemorrhages.No other information was provided.
Event or Problem Description
It was reported that the patient had experienced acute central retinal artery thrombosis approximately 32 hours post deployment of the subject flow diverter.The patient experienced acute loss of vision in ipsilateral eye of implantation.The subject flow diverter was implanted in the cavernous segment of the internal carotid artery (ica) and no difficulties were encountered during the procedure.Patient received 6mg of ia tpa in carotid and external artery as a medical intervention to treat the thrombosis and loss of vision.The vision improved after the patent received the medication.16 hours post tpa patient¿s scan showed many microhemorrhages and medical management was used to following indication of hemorrhages.No other information was provided.
Additional Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.Visual and functional testing could not be performed since the device was implanted in the patient.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.Based upon medical review, the harm observed in the 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 with the directions for use, product labeling and/or risk documentation files, an assignable cause of anticipated procedural complication will be assigned to this complaint.

• Brand Name: SURPASS EVOLVE 5.0MM X 40MM - PMAS
• Common Device Name: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• MDR Report Key: 10659909
• Report Number: 3008881809-2020-00297
• Device Sequence Number: 16936081
• Product Code: OUT
• UDI-Device Identifier: 07613327375329
• UDI-Public: 07613327375329
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P170024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2020

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: 04/22/2023
• Device Model Number: FDS50040
• Device Catalogue Number: FDS50040
• Device Lot Number: 22241704
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/15/2020
• Supplement Date Received by Manufacturer: 11/05/2020
• Initial Report FDA Received Date: 10/10/2020
• Supplement Report FDA Received Date: 12/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 64 YR