MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.0MM X 15MM - PMAS; INTRACRANIAL ANEURYSM FLOW DIVERTER

Catalog Number FDS40015

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Intraocular Pressure Increased (1937); Visual Disturbances (2140)

Event Date 10/29/2021

Event Type  Injury  

Manufacturer Narrative

Device is implanted in patient.

Event Description

It was reported that in a clinical trial, a procedure was done to treat a left internal carotid artery-ophthalmic (c6 segment) intracranial aneurysm with flow diversion.After a successful procedure with the subject flow diverter device to completely cover the target aneurysm with no device deficiencies noted, the patient reported a new pressure in their left eye during the 1 month follow up.There was no reported vision changes, blurred vision or photophobia associated.No imaging was performed in response to this event which was reported as recovering/resolving.Site reported event as possibly related to the subject flow diverter used.

Manufacturer Narrative

F10 / h6 health effect - corrected (from visual disturbance to intraocular pressure increased).Due to the automated mes 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.It was reported that the patient reported a pressure in their left eye which was new at the time of 1 month follow up.Otherwise, no vision changes, blurred vision or photophobia.No surgical delay or medical intervention was required.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 the as reported "patient complications" for this complaint.

Event Description

It was reported that in a clinical trial, a procedure was done to treat a left internal carotid artery-ophthalmic (c6 segment) intracranial aneurysm with flow diversion.After a successful procedure with the subject flow diverter device to completely cover the target aneurysm with no device deficiencies noted, the patient reported a new pressure in their left eye during the 1 month follow up.There was no reported vision changes, blurred vision or photophobia associated.No imaging was performed in response to this event which was reported as recovering/resolving.Site reported event as possibly related to the subject flow diverter used.

• Brand Name: SURPASS EVOLVE 4.0MM X 15MM - PMAS
• Type of Device: 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: 13637553
• MDR Text Key: 286364674
• Report Number: 3008881809-2022-00087
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P170024/S003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/18/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2024
• Device Catalogue Number: FDS40015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/04/2022
• Initial Date FDA Received: 03/01/2022
• Supplement Dates Manufacturer Received: 06/23/2022
• Supplement Dates FDA Received: 07/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 48 YR
• Patient Sex: Female
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White