MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.0MM X 20MM - IDE; INTRACRANIAL ANEURYSM FLOW DIVERTER

Catalog Number FDC40020

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

Patient Problem Visual Disturbances (2140)

Event Date 03/31/2021

Event Type  Injury  

Manufacturer Narrative

Device is not available to manufacturer.

Event Description

It was reported that during the clinical trial, 13 days post a successful procedure of an aneurysm in the internal carotid artery-ophthalmic (c6 segment) with the subject flow diverter, the patient experienced intermittent left eye visual disturbance.Relationship of the event to the procedure and subject device is reported as possible.An eye exam was performed by an optometrist on the same day which showed a normal retina with no issues.A diagnostic test was performed on (b)(6) 2021, which was an antiplatelet efficacy test and the platelet reaction unit (pru) was 52.There was no reported treatment initiated for the event.There was no imaging performed during the 1month visit on (b)(6) 2021.Event is reported to be ongoing but resolving.No other information is available.

Manufacturer Narrative

H4 manufacturing date ¿ added.D4 expiration date - added.Based on the results of the electronic device history record (edhr) review, there is no indication that the device, labeling or packaging failed to meet its specifications when released.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.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 patient complications is a known and anticipated complication to these types of procedures and patient condition and is listed as such in the device directions for use.Therefore, a probable cause of anticipated procedural complication was assigned to this event.

Event Description

It was reported that during the clinical trial, 13 days post a successful procedure of an aneurysm in the internal carotid artery-ophthalmic (c6 segment) with the subject flow diverter, the patient experienced intermittent left eye visual disturbance.Relationship of the event to the procedure and subject device is reported as possible.An eye exam was performed by an optometrist on the same day which showed a normal retina with no issues.A diagnostic test was performed on (b)(6) 2021, which was an antiplatelet efficacy test and the platelet reaction unit (pru) was 52.There was no reported treatment initiated for the event.There was no imaging performed during the 1month visit on (b)(6) 2021.Event is reported to be ongoing but resolving.No other information is available.

• Brand Name: SURPASS EVOLVE 4.0MM X 20MM - IDE
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• MDR Report Key: 11794882
• MDR Text Key: 249676211
• Report Number: 3008881809-2021-00189
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• PMA/PMN Number: P170024/S003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/02/2023
• Device Catalogue Number: FDC40020
• Device Lot Number: 22436459
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 45 YR