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

Catalog Number FD40020

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

Patient Problems Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)

Event Date 04/11/2022

Event Type  Injury  

Event Description

It was reported that the flow diverting stent (subject device) was successfully implanted in the right internal carotid artery-ophthalmic (c6 segment).Three months post procedure it was observed in the mri that the complete right ophthalmic carotid artery was occluded.There were no symptoms, but there was subject flow diverting stent thrombosis.The issue was resolved and there was no treatment required.According to the site, this event had a causal relationship with the study device and underlying condition or disease.The event also had a probable relationship with the dapt.No additional information available.

Manufacturer Narrative

Device remains implanted inside the patient.

Manufacturer Narrative

H4 manufacturing date ¿ added d4 expiration date ¿ added d4 lot # corrected - 22081695 to 22081695r.Due to the automated manufacturing execution system (mes) 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 complete right ophthalmic carotid occlusion.Study device thrombosis or occlusion.The issue was resolved.Site reports that no action or treatment was given for the adverse event.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 of 'patient vessel thrombosis' and 'patient vessel occlusion'.

Event Description

It was reported that the flow diverting stent (subject device) was successfully implanted in the right internal carotid artery-ophthalmic (c6 segment).Three months post procedure it was observed in the mri that the complete right ophthalmic carotid artery was occluded.There were no symptoms, but there was subject flow diverting stent thrombosis.The issue was resolved and there was no treatment required.According to the site, this event had a causal relationship with the study device and underlying condition or disease.The event also had a probable relationship with the dapt.No additional information available.

• Brand Name: SURPASS EVOLVE 4.0MM X 20MM - CE
• 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: 14960125
• MDR Text Key: 295523405
• Report Number: 3008881809-2022-00333
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 10/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/19/2023
• Device Catalogue Number: FD40020
• Device Lot Number: 22081695R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: AXS INFINITY LS (STRYKER); EXCELSIOR XT-27 MICROCATHETER (STRYKER); TERUMO BENTSON (UNKNOWN); TRAXCESS 14 GUIDEWIRE (MICROVENTION)
• Patient Outcome(s): Other
• Patient Age: 35 YR
• Patient Sex: Female