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

Model Number MV-L553021

Device Problems Difficult to Remove (1528); Device Dislodged or Dislocated (2923)

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

Event Date 07/08/2021

Event Type  Injury  

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 the delivery system was not returned to the manufacturer for analysis; therefore, the alleged product issue cannot be confirmed.The instructions for use (ifu) identifies device migration as potential complications associated with use of the device.Ifu precautions indicate "exercise caution when crossing the deployed/detached lvis device with adjunctive devices such as guidewires, catheters, microcatheters or balloon catheters to avoid disrupting the device geometry and device placement.".

Event Description

It was reported that after the stent was deployed at the desired target location (the right ic, proximal to c4), the delivery wire was unable to be removed as it encountered resistance in the stent.The reaction of the force attempting to withdraw the wire nearly drew the headway21 microcatheter into the stent.Eventually, the wire and the microcatheter were removed from the patient successfully; however, the stent became dislodged proximal to the target location.The cause of the delivery wire getting stuck in the stent was unknown.The physician decided not to remove the stent as it achieved good vessel apposition despite not being positioned properly at the target location.The patient will be followed up.No patient injury was reported.

• 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 drive; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 12277618
• MDR Text Key: 265145556
• Report Number: 2032493-2021-00308
• Device Sequence Number: 1
• Product Code: QCA
• UDI-Device Identifier: 04987892041518
• UDI-Public: (01)04987892041518(11)201028(17)230930(10)201028562
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: MV-L553021
• Device Lot Number: 201028562
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2020
• 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