MAUDE Adverse Event Report: TORAX MEDICAL, INC. 1.5T LINX, 17 BEADS; ANTI-REFLUX IMPLANT

Catalog Number LXMC17

Device Problems Migration or Expulsion of Device (1395); Device Appears to Trigger Rejection (1524); Patient Device Interaction Problem (4001)

Patient Problems Dysphagia/ Odynophagia (1815); Pocket Erosion (2013)

Event Date 01/01/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 12/18/2023.B3: only event year known: 2023.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 or batch number was provided therefore a device history could not be done.Additional information received: the product lxmc17 eroded into the patients esophagus and the surgeons were unable to remove it for the first 2 surgeries.It broke 2 cutting devices and then on the 3rd surgery, they had to cut it with a harmonic device.They were only able retrieve 5 out of the 17 links.They attempted to cut the link endoscopically, but the harmonic did not reach.They ended up having to make a hole in the stomach to access the linx.They were only able to retrieve 5 of the 17 linx.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? what is the lot number? what was the explant date (s)? what was the date of implant? 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? why was the reason it took 3 surgeries to remove the device? were there technical challenges? what was the experience of the surgeon who removed it? 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.

Event Description

It was reported that the linx device eroded into the esophagus and was unable to be cut with with normal procedure.There were three surgeries conducted to get it done.No further information was provided.

Manufacturer Narrative

(b)(4).Date sent: 1/18/2024.Additional information received: i thought he said there were pictures.I sent two emails requesting any from him.No reply.

Manufacturer Narrative

(b)(4).Date sent: 1/18/2024.Additional information received: implanted (b)(6) 2021.Explanted partially (b)(6) 2023.11/16 came to clinic complaining of belching, pressure with swallowing, dysphagia ¿ symptoms for a few weeks but worsening over time no procedure between implant and symptoms.She was doing great.Pics available.Removed 5 beads with partial explants.Beads were posterior.Removed laparoscopically with transgastric approach ¿ we attempted x 3 to remove endoscopically but endoscopic wire cutters broke trying to cut wire and were not able to cut through the wire.I tried three separate wire cutters.We then discussed and planned for laparoscopic removal of the eroded beads by creating a gastrotomy.This prevents the beads from having a complete through and through erosion through the esophagus.We removed the eroded beads and left the intact beads in place.They can be laparoscopically removed another date after the erosion heals.No stent.Patient is very happy, relieved, eating and swallowing well.Reason for 3 procedures described above.Technical challenges ¿ wire too strong for ethicon wire cutter.

• Brand Name: 1.5T LINX, 17 BEADS
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4545 creek road; cincinnati OH
• Manufacturer Contact: kate karberg ; 4545 creek rd.; cincinnati, OH 45242 ; 3035526892
• MDR Report Key: 18347693
• MDR Text Key: 330772160
• Report Number: 3008766073-2023-00254
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005370
• UDI-Public: 00855106005370
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 01/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: LXMC17
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention