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

Model Number LXC-[14]

Device Problems Migration or Expulsion of Device (1395); Device Appears to Trigger Rejection (1524); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Chest Pain (1776); Dysphagia/ Odynophagia (1815); Pocket Erosion (2013); Weight Changes (2607)

Event Date 06/24/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent; (b)(6) 2022 unknown; captured as awareness date.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 product code of the linx device? what is the lot number? what was the date of implant? if the device has been removed, what was the date of explant? 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?.

Event Description

It was reported that there was a linx device erosion with planned explant.Patient lost 50 lbs.Explant may take place.No additional information was received.

Manufacturer Narrative

(b)(4), date sent: 7/7/2022.Lot number was received and dhr is pending review.When the review is completed, a supplemental medwatch will be sent with a summary of the evaluation.Linx photo images were received and are pending review.When the review is completed, a supplemental medwatch will be sent with a summary of the evaluation.Additional information was requested, and the following was obtained: what is the product code of the linx device? lxc-14.What is the lot number? 6452 sr#7845.What was the date of implant? (b)(6) 2014.If the device has been removed, what was the date of explant? patient was referred to osu services of (b)(6).What were the first clinical symptoms that provided evidence of an erosion and when did they first occur? dysphagia.Has the patient had any dilations, egd, or other procedure between the linx implant and discovery of the (b)(6) 2022 esophageal manometry, (b)(6) 2021 egd, (b)(6) 2019 egd evaluation under fluro/bravo capsule, (b)(6) 2018 egd/bravo erosion? please describe and include the dates of the procedures.Are pictures or videos available? pictures were taken how many beads eroded? 3.Where were the eroded beads positioned? distal.Which best describes the device removal approach? this patient was referred to osu 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? patient was stable when they left our facility.Additional information provided: erosion discovered during egd on (b)(6) 2022.Removal on (b)(6) 2022.Egd report attached 56 yo male, initials (b)(6), general health¿cardiac issues.Patient has been seen annually for follow up after linx.Has done well post linx, last check was sep 2021¿egd clear, fluoro showed device in good position.Patient experienced chest pain, painful, difficult swallowing, x2 months.Lost 50lbs--could only eat chicken soup and suck on crackers.Manometry (b)(6) 2022 with no change.Had to wait for cardiac clearance for anesthesia before doing egd.Egd on (b)(6) 2022 showed 3 beads in the lumen (see attached report).Patient referred to (b)(6), (b)(6) (experienced linx surgeon) for removal.Coordinator will call patient tomorrow and provide update on status.

Manufacturer Narrative

(b)(4), date sent: 8/17/2022.Photo analysis: as per medical safety officer: "the endoscopy report describes device erosion and device location below the diaphragm.The photographs demonstrate the linx beads visible within the lumen of the esophagus".Hands-on analysis of the device is necessary to determine the cause of esophageal erosion.A manufacturing record evaluation was performed for the finished device batch number 6452, and no non-conformances were identified.Additional information received: the dhr for lot number 6452 states product code 3718-12, which is lxc12.

• Brand Name: LXC12
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• Manufacturer Contact: orla o'mahony ; 4188 lexington avenue north; shoreview 55126
• MDR Report Key: 14854885
• MDR Text Key: 294942109
• Report Number: 3008766073-2022-00133
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005134
• UDI-Public: 00855106005134
• Combination Product (y/n): N
• PMA/PMN Number: P100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/15/2018
• Device Model Number: LXC-[14]
• Device Catalogue Number: LXC12
• Device Lot Number: 6452
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male