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

Model Number LEV4021-MVE

Device Problem Activation Failure (3270)

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

Event Date 09/27/2023

Event Type  Injury  

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 device was reported 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 the physician was treating a dissection on the left internal carotid artery (ica) to include the implantation of the lvis evo.The stent did not deploy inside the vessel, and after the stent was pushed out of the balloon and detached inside the target vessel; however, it did not deploy in the middle portion.The lvis evo was removed from the vessel with a goose neck snare.The stent was exchanged to another stent, and the examination continued with good result.The patient is doing well, with no injury caused by the reported complaint.

Manufacturer Narrative

Investigation findings: items returned for investigation: stent.Items not returned for investigation: pusher, introducer.The stent was returned fully deployed; the returned stent measured within specification.The stent was loaded onto an in-house pusher with an in-house introducer and was able to fully open upon deployment during the investigation.Investigation conclusion: the stent was able to fully open upon deployment.The investigation of the returned device did not find any damage or other anomaly that would have caused or contributed to the reported complaint.

Event Description

Please see section h10 for investigation results.

• Brand Name: LVIS EVO
• 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: 18166327
• MDR Text Key: 328482262
• Report Number: 2032493-2023-01060
• Device Sequence Number: 1
• Product Code: QCA
• UDI-Device Identifier: 00842429103562
• UDI-Public: (01)00842429103562(11)230213(17)260131(10)0000320760
• 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: 12/13/2023

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: LEV4021-MVE
• Device Lot Number: 0000320760
• 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: 11/03/2023
• Initial Date FDA Received: 11/17/2023
• Supplement Dates Manufacturer Received: 11/30/2023
• Supplement Dates FDA Received: 12/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/13/2023
• 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
• Patient Age: 39 YR
• Patient Sex: Female