MAUDE Adverse Event Report: MICROVENTION INC. LVIS EVO; INTRALUMINAL DEVICES

Model Number LEV4031-MVE

Device Problem Retraction Problem (1536)

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

Event Date 10/27/2022

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to the manufacturer for analysis; therefore, the alleged product issue cannot be confirmed.If the device or additional information is received, microvention, inc., will submit a supplemental mdr report.The instructions for use (ifu) identifies retraction difficulty as potential complications associated with use of the device.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.

Event Description

It was reported that an lvis evo was placed.It was decided to change the stent position however, the stent could not be moved and retracted into the microcatheter.The system was removed.The case was completed successfully with another lvis evo.No patient harm or injury was reported.

Manufacturer Narrative

A follow-up report is being submitted to make correction from: fei-based, to: cfn based.Fei was selected in error on our initial report.Please see attached acknowledgements 1 through 3.The patient identifier in section a1 has been changed to: (b)(6).The investigation found the stent returned fully deployed and the pusher kinked at the core wire taper.Due to the kink in the returned pusher, an in-house pusher was used for the investigation testing.The stent was able to advance through an in-house microcatheter without resistance and be resheathed successfully back into the microcatheter during functional testing.The physical evaluation of the device could not identify the conditions or circumstances that led to the pusher damage, but the damage is consistent with the device experiencing forces over specification.The microcatheter used in the procedure was not evaluated as a part of this evaluation, so the investigation could not determine if it had caused or contributed to the reported complaint.

• Brand Name: LVIS EVO
• Type of Device: INTRALUMINAL DEVICES
• 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: 15789811
• MDR Text Key: 307768964
• Report Number: 0002032493-2022-00524
• Device Sequence Number: 1
• Product Code: QCA
• UDI-Device Identifier: 00842429103586
• UDI-Public: (01)00842429103586(11)220511(17)250430(10)0000189957
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LEV4031-MVE
• Device Lot Number: 0000189957
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/13/2022
• Initial Date FDA Received: 11/14/2022
• Supplement Dates Manufacturer Received: 12/12/2022
• Supplement Dates FDA Received: 12/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2022
• 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): Other
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 82 KG