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

Model Number LEV4018-MVE

Device Problem Premature Separation (4045)

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

Event Date 10/29/2020

Event Type  malfunction  

Manufacturer Narrative

A search for non-conformance 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 implanted in the patient and not returned to the manufacturer for analysis.Images were provided.The first provided fluoroscopic image shows a basilar tip aneurysm prior to treatment.The second provided image shows the lvis stent positioned as expected at an almost 90 degrees across the aneurysm.Provided images 3 and 4 show the stent appearing to be dislocated to the vertebral artery.Provided image 5 shows the basilar tip aneurysm treated with another stent and coiled.These images are consistent with the complaint, but without the return and physical evaluation of the actual device, the investigation could not determine if the device caused or contributed to the alleged product issue.At the time this complaint was received, this product was an exported device that was not cleared or approved for marketing in the u.S.The complaint is being reported now as based on this product meeting similar product criteria.

Event Description

It was reported that during deployment of the stent to treat a basilar tip aneurysm, fluoroscopy was interrupted for a short time after the stent was opened 90%.Upon resuming fluoroscopy, it was noted that the microcatheter and stent system had moved and the stent had completely deployed in the proximal vertebral artery.The stent was left in position and another stent was successfully implanted at the planned treatment site.There was no reported patient injury or additional intervention.

• 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 drive; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 13115452
• MDR Text Key: 284814053
• Report Number: 2032493-2021-00526
• Device Sequence Number: 1
• Product Code: NJE
• UDI-Device Identifier: 00842429103555
• UDI-Public: (01)00842429103555(11)200606(17)230531(10)200606529
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: LEV4018-MVE
• Device Lot Number: 200606529
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/29/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2020
• 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 Age: 70 YR