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

Model Number MV-L451821

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/16/2022

Event Type  malfunction  

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 discarded at the user facility and not returned to the manufacturer for evaluation.Without the return and physical evaluation of the device, the investigation is unable to determine if a condition existed that would have caused or contributed to the reported event.The event as described could not be confirmed.

Event Description

It was reported that a flow diverter fully deployed unintentionally during repositioning and was recaptured with the use of a snare during a stent-assisted coil embolization procedure.As per the conventional procedure, the microcatheter was navigated distal to the aneurysm.The stent was partially deployed for positioning; however, the stent was unable to be deployed as intended due to the siphon part of the vessel.While recapturing and repositioning the stent several times, the stent fully deployed unintentionally.However, the proximal flare was unable to be fully expand.The stent was retracted into the microcatheter using a snare and removed from the patient along with the microcatheter.A new lvis stent of the same size was used to continue the procedure.Subsequently, the procedure was completed successfully.There was no patient injury.

• Brand Name: LVIS
• 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
• MDR Report Key: 15612460
• MDR Text Key: 306593167
• Report Number: 2032493-2022-00393
• Device Sequence Number: 1
• Product Code: QCA
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 09/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MV-L451821
• Device Lot Number: 0000130771
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2021
• 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