MAUDE Adverse Event Report: TORAX MEDICAL, INC. LXC12; ANTI-REFLUX IMPLANT

Model Number LXC-[12]

Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Pain (1994); Pocket Erosion (2013); Insufficient Information (4580)

Event Date 01/01/2023

Event Type  Injury  

Event Description

It was reported that a linx device was implanted in 2011 and has been removed/explanted.

Manufacturer Narrative

(b)(4).Date sent: 3/9/2023.Only event year known: 2023 exact date unknown.Device was implanted in 2011.Assuming first month of the year and first day of the month.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.No lot number was provided therefore a device history could not be done.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: what is the exact date that the implant took place? on what date did the explant take place? what is the product code? lot #? does the patient have any of the allergies to metals? if so, what test have been done to test for metal allergies.Is the patient currently taking currently taking steroids / immunosuppressive drugs? did the patient have any pre-existing dysphagia or other conditions (other than gerd)? was there any hiatal or crural repair done at the same time as the implant? was mesh used at time of implant? what was the reason for removal of the linx device? at the time of removal, was the device found in the correct position/geometry at the time of removal? have the symptoms resolved since the device was explanted? this report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Pc-(b)(4).Date sent: 3/24/2023.Additional information was requested, and the following was obtained: what is the exact date that the implant took place? 28th june 2012 on what date did the explant take place? (b)(6) 2023.What is the product code? lot #? 12 beads / lot# n/a does the patient have any of the allergies to metals? if so, what test have been done to test for metal allergies.-> np.Is the patient currently taking currently taking steroids / immunosuppressive drugs? ->no.Did the patient have any pre-existing dysphagia or other conditions (other than gerd)? -> no.Was there any hiatal or crural repair done at the same time as the implant? -> np.Was mesh used at time of implant? no.What was the reason for removal of the linx device? -> erosion.At the time of removal, was the device found in the correct position/geometry at the time of removal? yes.Have the symptoms resolved since the device was explanted? yes.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: what were the first clinical symptoms that provided evidence of an erosion and when did they first occur? has the patient had any dilations, egd, or other procedure between the linx implant and discovery of the erosion? please describe and include the dates of the procedures.Are pictures or videos available? how many beads eroded? where were the eroded beads positioned? which best describes the device removal approach? endoscopically removed the eroded beads initially & laparoscopically removed the device at a later date endoscopically removed the eroded beads & laparoscopically removed the device the same day endoscopically removed the entire device laparoscopically removed the entire device was the patient stented? what is the current condition of the patient?.

Manufacturer Narrative

(b)(4).Date sent: 5/8/2023.Additional information received: the exact product code is lxc ¿ 12 , the original code reported in the report was wrong.

Manufacturer Narrative

(b)(4).Date sent: 4/25/2023.Additional information was requested, and the following was obtained: what were the first clinical symptoms that provided evidence of an erosion and when did they first occur? ep.Pain.Has the patient had any dilations, egd, or other procedure between the linx implant and discovery of the erosion? please describe and include the dates of the procedures.No.Are pictures or videos available? no.How many beads eroded? 4.Where were the eroded beads positioned? gej.Which best describes the device removal approach? laparoscopically removed the entire device.Was the patient stented? no.What is the current condition of the patient? ok.

Manufacturer Narrative

(b)(4).Date sent: 5/23/2023 investigation summary overall review of the device function and dimensions show no anomalies from a device that has been reasonably changed as part of the explant procedure.Visual analysis was consistent with an explanted device, and link length and tensile force were found to meet the applicable specifications.Overall, no analysis conclusions relevant to the patient experience were found.

Manufacturer Narrative

(b)(4).Date sent: 5/23/2023.

• Brand Name: LXC12
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• Manufacturer Contact: kate karberg ; 4188 lexington avenue north; shoreview ; 3035526892
• MDR Report Key: 16512163
• MDR Text Key: 310963054
• Report Number: 3008766073-2023-00033
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005134
• UDI-Public: 00855106005134
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LXC-[12]
• Device Catalogue Number: LXC12
• Device Lot Number: UNKNOWN_LINX (TORAX)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention