MAUDE Adverse Event Report: MICROVENTION, INC. LVIS D; INTRALUMINAL SUPPORT DEVICE

Model Number MV-L402221

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

Patient Problems Hemorrhage/Bleeding (1888); Obstruction/Occlusion (2422)

Event Date 04/20/2023

Event Type  Injury  

Manufacturer Narrative

The device was stated to be available for return to the manufacturer for evaluation but has not yet been returned.The reported issue could not be confirmed.If the device is received at a later date, an investigation will be performed and a supplemental mdr will be submitted.

Event Description

It was reported that during the placement of the stent in an internal carotid posterior communicating artery (ic-pc) aneurysm, a hemorrhage was observed in the middle cerebral artery (mca).Therefore, placement of the stent was aborted.Hemostasis was attempted using a balloon; however, the situation was unable to be improved.Parent artery occlusion was performed on the mca with coils and glue embolization (nbca).Subsequently, the procedure was completed.

Event Description

Please see section h10 for device investigation results.

Manufacturer Narrative

A search for non-conformances associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The investigation of the returned stent system found the stent returned loaded in the introducer.Replication testing was performed and found that the stent was able to successfully advance through the returned microcatheter and fully open upon deployment.There was no residual blood on the stent or pusher, and no blood was found inside the introducer or microcatheter lumen during the investigation.The investigation of the returned device did not find any damage or other anomaly that would have caused or contributed to the reported complaint.Without the review of images from the medical procedure, this investigation is unable to verify the if the hemorrhage occurred during the deployment of the stent system as described in the reported event.

• Brand Name: LVIS D
• Type of Device: INTRALUMINAL SUPPORT DEVICE
• 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: 16913583
• MDR Text Key: 315030926
• Report Number: 2032493-2023-00720
• Device Sequence Number: 1
• Product Code: QCA
• UDI-Device Identifier: 04987892063152
• UDI-Public: (01)04987892063152(11)220117(17)241231(10)0000143397
• 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: 07/05/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: MV-L402221
• Device Lot Number: 0000143397
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/20/2023
• Initial Date FDA Received: 05/11/2023
• Supplement Dates Manufacturer Received: 07/05/2023
• Supplement Dates FDA Received: 07/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/17/2022
• 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