MAUDE Adverse Event Report: TORAX MEDICAL, INC. 1.5T LINX, 13B; ANTI-REFLUX IMPLANT

Model Number LXMC13

Device Problems Migration or Expulsion of Device (1395); Patient Device Interaction Problem (4001)

Patient Problems Erosion (1750); Dysphagia/ Odynophagia (1815); No Code Available (3191)

Event Date 05/15/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 6/5/2020.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.Additional information was requested, and the following was obtained: 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? what is the product code for the linx device that was removed? what is the lot number of the linx device? 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? response received: male patient.(b)(6).Bmi 22.05.Healthy, no significant medical history besides gerd.Allgy: pcn.No apparent trauma or event that would have initiated an erosion.No trauma or extenuating circumstances, patient is a healthy (b)(6) year old male, bmi of 22.Had been doing well until just recently¿presented with dysphagia to outside provider, egd showed beads in lumen.What was the date of implant? (b)(6) 2016.What were the first clinical symptoms that provided evidence of an erosion and when did they first occur? dysphagia prompted an egd by an outside provider on 7may 2020.Patient had been doing well up to that point.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.None.Are pictures or videos available? yes, i have the video.What is the product code for the linx device that was removed? lxmc13.What is the lot number of the linx device? 8420.How many beads eroded? 5-6 including the clasp.Where were the eroded beads positioned? anterior erosion on the gastric side of the gej.Which best describes the device removal approach? endoscopically removed the entire device.Was the patient stented? no.What is the current condition of the patient? has not seen back in follow up but assuming patient is doing fine.Per video evaluation by ethicon medical: i reviewed a video related to (b)(4) regarding an endoscopy procedure.The video showed an upper endoscopy procedure.On antegrade examination the esophagus appeared normal.There was evidence of an eroded linx msa device that showed the clasp and one or 2 beads.The erosion appeared anteriorly in the esophagus approximately 1 cm below the squamo-columnar junction.On retroflexed view the erosion was again evident.There was some food debris attached to the beads.The linx joining wire was cut with an endoscopic cutter.The device was then removed endoscopically through the esophagus.An intact 13- bead device was removed.Inspection after removal showed some swelling at the gej but no excessive bleeding.Assessment is that the video depicted a 13-bead device that had eroded through into the esophagus that was successfully removed endoscopically.

Event Description

It was reported that a linx device had eroded into the esophagus and was removed endoscopically.It is unknown if there were any adverse consequences to the patient.

• Brand Name: 1.5T LINX, 13B
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• Manufacturer Contact: kara ditty-bovard ; 4188 lexington avenue north; shoreview, MN ; 6107428552
• MDR Report Key: 10122914
• MDR Text Key: 194780093
• Report Number: 3008766073-2020-00074
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005332
• UDI-Public: 00855106005332
• 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
• Report Date: 05/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/18/2019
• Device Model Number: LXMC13
• Device Catalogue Number: LXMC13
• Device Lot Number: 8420
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/15/2020
• Initial Date FDA Received: 06/05/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2015
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 35 YR