MAUDE Adverse Event Report: TORAX MEDICAL, INC. 1.5T LINX, 15B; ANTI-REFLUX IMPLANT

Catalog Number LXMC15

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

Patient Problems Dysphagia/ Odynophagia (1815); Pain (1994)

Event Date 06/28/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 11/9/2023.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 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: prior to linx placement, did the patient have an egd, ph, and manometry studies done? if yes, could you please share the results? on what date did the implant take place? what is the lot number of the linx device? when using the linx sizing device what technique was used to determine the size? did the patient have an autoimmune disease? is the patient currently taking steroids / immunosuppressive drugs? did the patient have any pre-existing dysphagia or other conditions (other than gerd)? how severe was the dysphagia/odynophagia before intervention? were there any intra-operative complications during implant? was there any hiatal or crural repair done at the same time as the implant? were there any other contributing factors that led to the removal of the device other than the reported dysphagia? besides the reported dysphagia, what was the reason for removal of the linx device? was the device found in the correct position/geometry at the time of removal? 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

A linx was removed due to dysphagia.

Manufacturer Narrative

(b)(4).Date sent: 12/11/2023 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.Additional information was requested, and the following was obtained: prior to linx placement, did the patient have an egd, ph, and manometry studies done? if yes, could you please share the results? 11/15/2021/egd/bravo 96 hour demeester 50.2 gi path/lower-esophagus- squamous mucosa with mild reparative changes/colon-sessile serrated adenoma small hiatal hernia on what date did the implant take place? (b)(6) 2022 what is the lot number of the linx device? 28446 when using the linx sizing device what technique was used to determine the size? the sizing device was used and repeatedly the esophagus was determined to need a size 15 linx (generally 3 beads above the actual size).Did the patient have an autoimmune disease? multiple myeloma is the patient currently taking steroids / immunosuppressive drugs? none known did the patient have any pre-existing dysphagia or other conditions (other than gerd)? the marshmallow bagel barium swallow reports 2 stripping waves for both the marshmallow and the bagel and a small hiatal hernia.Severe motion sickness, low hemoglobin, burning pain and regurgitation how severe was the dysphagia/odynophagia before intervention? (b)(6) 2022-office note reports the patient having an increase in dysphagia for 2 days and an increase in hiccups-he was prescribed valium and chlorpromazine (b)(6) 2022-pt complained of dysphagia and pooling as well as pain that radiate from his abdomen to his chest and back.Prednisone 20mg x 10 days and levsin 0.125mg tid were prescribed.09/22/2022/no reflux but he continues to have challenges with dysphagia and odynophagia.06/14/2022-amitriptyline 10mg, qd 07/20/2022/dilation linx 08/08/2022- prednisone 20mg x 10 days 09/23/2022/dilation linx 04/17/2023-esophageal manometry-les baseline pressure with abnormal deglutitive les/egj relaxation/less than 30% effective swallows= egk outflow obstruction 06/28/2023-removal linx were there any intra-operative complications during implant? no was there any hiatal or crural repair done at the same time as the implant? yes were there any other contributing factors that led to the removal of the device other than the reported dysphagia? episodes of radiating pain besides the reported dysphagia, what was the reason for removal of the linx device? episodes of radiating pain was the device found in the correct position/geometry at the time of removal? yes.

Manufacturer Narrative

(b)(4).Date sent: 1/22/2024.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 with significant tooling marks in some beads.Link length and tensile force were found to meet the applicable specifications.Overall, no analysis conclusions relevant to the patient experience were found.A manufacturing record evaluation was performed for the finished device 28446 number, and no non-conformances related to the malfunction were identified.

• Brand Name: 1.5T LINX, 15B
• 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: 18102154
• MDR Text Key: 327737622
• Report Number: 3008766073-2023-00223
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005356
• UDI-Public: 00855106005356
• 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: 01/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: LXMC15
• Device Lot Number: 28446
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2021
• 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