MAUDE Adverse Event Report: MICROVENTION, INC. LVIS D; INTRACRANIAL COIL-ASSIST STENT

Model Number 215530-CAS-D-CN

Device Problems Difficult to Open or Close (2921); Activation Failure (3270)

Patient Problems Thrombocytopenia (4431); Thrombosis/Thrombus (4440)

Event Date 08/27/2023

Event Type  Injury  

Event Description

As reported, the lvis stent was used to treat a basilar aneurysm.The carrier artery was thick overall but narrow proximally.After the stent was in place, the proximal end of the stent could not be opened and thrombosis was found after the second adjustment.After thrombus formation, the stent was removed and blood flow was restored after the thrombus was aspirated using a distal access catheter.Another lvis stent was used to complete the case.The patient is fine.

Manufacturer Narrative

A search for non-conformances associated with the reported part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device was returned to the manufacturer for analysis and the investigation is currently underway.A supplemental report will be submitted when the investigation is completed.The instructions for use (ifu) identifies stent thrombosis as potential complications associated with use of the device.

Manufacturer Narrative

Correction: h6 (device code).Additional information: h6, h10 (summary device evaluation).Summary of device evaluation: investigation conclusion: the investigation of the returned stent system found the stent returned fully deployed.Replication testing was performed and found the stent was able to successfully advance through the returned microcatheter and fully open upon deployment.The anatomy may have contributed to the reported event; however, this investigation could not replicate the anatomical environment to test and assess the device in the exact conditions experienced during the procedure.Furthermore, this investigation could not verify the occurrence of reported thrombus without the review of supplemental imaging from the procedure and therefore, this complaint is considered non-verifiable.The investigation of the returned device did not find any damage or other anomaly that would have caused or contributed to the reported complaint.

• Brand Name: LVIS D
• Type of Device: INTRACRANIAL COIL-ASSIST STENT
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 17800100
• MDR Text Key: 324055388
• Report Number: 2032493-2023-00954
• Device Sequence Number: 1
• Product Code: QCA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P170013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/06/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 215530-CAS-D-CN
• Device Lot Number: 0000252872
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/07/2023
• Initial Date FDA Received: 09/22/2023
• Supplement Dates Manufacturer Received: 10/25/2023
• Supplement Dates FDA Received: 11/06/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/05/2022
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 62 KG