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

Catalog Number FDC40015

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

Patient Problem Vasoconstriction (2126)

Event Date 11/16/2021

Event Type  Injury  

Manufacturer Narrative

Device is implanted in patient.

Event Description

It was reported that during a clinical trial procedure using the subject flow diverter, the patient had a vasospasm.The vasospasm was slight and did not affect blood flow.It occurred after the subject flow diverter was resheathed a few times to achieve perfect distal location.The blood pressure was elevated for a few minutes and nimotop was added to the distal access catheter flush.The light spasm calmed down in 10 minutes and resolved.

Manufacturer Narrative

Due to the automated manufacturing execution system there are controls in the manufacturing process to ensure the product met specifications upon release.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 event reported "vasospasm (after a stent release a slight vasospasm occur, which did not affected on the blood flow)".Additional information provided by the customer indicated that they believed the reported issue was caused by device re-sheathing, and the manipulation of the device in middle cerebral artery was the reason for the vasospasm.Based upon medical review, the harm observed in this complaint is anticipated in nature as per the device risk assessment.An assignable cause of procedural factors will be assigned to the reported 'patient vasospasm serious' as the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.

Event Description

It was reported that during a clinical trial procedure using the subject flow diverter, the patient had a vasospasm.The vasospasm was slight and did not affect blood flow.It occurred after the subject flow diverter was resheathed a few times to achieve perfect distal location.The blood pressure was elevated for a few minutes and nimotop was added to the distal access catheter flush.The light spasm calmed down in 10 minutes and resolved.

• Brand Name: SURPASS EVOLVE 4.0MM X 15MM - IDE
• 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: 13055169
• MDR Text Key: 282586235
• Report Number: 3008881809-2021-00537
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: FI
• 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: 03/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/02/2022
• Device Catalogue Number: FDC40015
• Device Lot Number: 21805681
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2019
• 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
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 41 YR
• Patient Sex: Female