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

Catalog Number LXMC13

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Pocket Erosion (2013)

Event Date 01/01/2024

Event Type  Injury  

Event Description

It was reported that a linx device eroded.

Manufacturer Narrative

(b)(4).Date sent: 1/25/2024 b3: only event year known: 2024 an analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.However, if the product is received at a later date, the investigation will be updated as applicable.No lot number was provided therefore a device history could not be done.Photo images were received.Any additional information obtained from the photo evaluation will be included as part of the product investigation.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 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? 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

(b)(4).Date sent: 2/5/2024.D6b: exact date is unk.Assumed first day of the month.Additional information was requested, and the following was obtained: what is the lot number? unknown what was the date of implant? (b)(6) 2018.If the device has been removed, what was the date of explant? (b)(6) 2023 what were the first clinical symptoms that provided evidence of an erosion and when did they first occur? unknown.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.Unknown.Are pictures or videos available? attached.How many beads eroded? unknown.Where were the eroded beads positioned? which best describes the device removal approach? endoscopically removed the entire device.Was the patient stented? unknown.What is the current condition of the patient? good.

Manufacturer Narrative

(b)(4).Photo analysis: x-ray images of the device in vivo were reviewed by a medical safety officer.As per medical safety officer: "the esophagram images reviewed demonstrate what appears to be an intact linx device within the gastric lumen.The image demonstrates an intact linx device located below the diaphragm." the mechanism/cause of failure is unknown as a hands-on analysis of the device is necessary to determine the cause of failure.No further investigation can be completed at this point.

• Brand Name: 1.5T LINX, 13B
• 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: 18580918
• MDR Text Key: 333739356
• Report Number: 3008766073-2024-00017
• 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,Followup,Followup
• Report Date: 02/27/2024

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: LXMC13
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/25/2024
• Supplement Dates Manufacturer Received: 01/25/2024; 02/26/2024
• Supplement Dates FDA Received: 02/05/2024; 02/27/2024
• 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