MAUDE Adverse Event Report: TORAX MEDICAL, INC. 1.5T LINX, 14B; ANTI-REFLUX IMPLANT

Model Number LXMC14

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

Patient Problems Dysphagia/ Odynophagia (1815); Pyrosis/Heartburn (1883); Pain (1994); Vomiting (2144)

Event Date 05/09/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 5/22/2023.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? was the device found in the correct position/geometry at the time of removal? was ph testing performed prior to explant to confirm recurrent reflux? after implant, was the device initially effective in controlling reflux? when did the recurrent reflux begin? 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 there was an explant of a linx device due to vomiting, heartburn, atypical chest pain, pain swallowing meds.

Manufacturer Narrative

(b)(4).Date sent: 6/7/2023.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? egd on (b)(6) 2020; dilation, tortuous esophagus, small hiatal hernia, visualized barrett¿s pathology: gastritis and esophagitis.History of barrett¿s esophagus.Classic reflux symptoms, on dexilant with breakthrough symptoms lpr-diagnosed by ent.Normal esophageal motility noted on marshmallow bagel barium swallow: on (b)(6) 2021.On what date did the implant take place? on (b)(6) 2021.What is the lot number of the linx device? 27239.When using the linx sizing device what technique was used to determine the size? 14.Did the patient have an autoimmune disease? ulcerative colitis.Is the patient currently taking steroids / immunosuppressive drugs? simponi injection.Did the patient have any pre-existing dysphagia or other conditions (other than gerd)? aortic valve disorder-tavr, hypertensive disorder, osteopenia, osteoporosis, pancreatitis, ulcerative colitis- post-op diagnosed with takotsubo cardiomyopathy.How severe was the dysphagia/odynophagia before intervention? treated with prednisone 20mg x 10 days on (b)(6) 2021; egd dilation on (b)(6) 2022; she had atypical chest pain.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.Was the device found in the correct position/geometry at the time of removal? yes.Was ph testing performed prior to explant to confirm recurrent reflux? no.After implant, was the device initially effective in controlling reflux? yes.When did the recurrent reflux begin? she did not have recurrent reflux.

Manufacturer Narrative

(b)(4).Date sent: 6/20/2023.A manufacturing record evaluation was performed for the finished device lot number: 27239, and no related nonconformances were identified.

Manufacturer Narrative

(b)(4).Date sent: 6/26/2023.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, and link length and tensile force were found to meet the applicable specifications.Overall, no analysis conclusions relevant to the patient experience were found.

• Brand Name: 1.5T LINX, 14B
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4545 creek road; cincinnati OH
• Manufacturer Contact: kate karberg ; 4188 lexington avenue north; shoreview ; 3035526892
• MDR Report Key: 16973048
• MDR Text Key: 315666608
• Report Number: 3008766073-2023-00086
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005349
• UDI-Public: 00855106005349
• 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,Followup
• Report Date: 06/26/2023

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 Expiration Date: 12/11/2021
• Device Model Number: LXMC14
• Device Catalogue Number: LXMC14
• Device Lot Number: 27239
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/08/2023
• Initial Date FDA Received: 05/22/2023
• Supplement Dates Manufacturer Received: 05/25/2023; 06/09/2023; 06/23/2023
• Supplement Dates FDA Received: 06/07/2023; 06/20/2023; 06/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/11/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention