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

Catalog Number LXMC14

Device Problems Device Appears to Trigger Rejection (1524); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Abscess (1690); Dysphagia/ Odynophagia (1815); Vomiting (2144)

Event Date 10/18/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 10/30/2023.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.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 received: prior to linx placement, did the patient have an egd, ph, and manometry studies done? if yes, could you please share the results? yes.On what date did the implant take place? (b)(6) 2019.What is the lot number of the linx device? 24128 / size 14.When using the linx sizing device what technique was used to determine the size? wand using 3 measurement technique.Did the patient have an autoimmune disease? no.Is the patient currently taking steroids / immunosuppressive drugs? no.Did the patient have any pre-existing dysphagia or other conditions (other than gerd)? hiatal hernia.How severe was the dysphagia/odynophagia before intervention? patient had three dilations last spring and despite being dilated up to 20 mm and seeing 9 of the beads moving on fluoroscopy he still has the same issue.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, hiatal were there any other contributing factors that led to the removal of the device other than the reported dysphagia? yes, regurgitation daily.Besides the reported dysphagia, what was the reason for removal of the linx device? regurgitation daily was the device found in the correct position/geometry at the time of removal? yes additional information was requested, and the following was obtained: what does the surgeon believe was the cause of the puss noted in the surgery? answer : he could not be certain if it was from mesh, device or previous dilatation.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 implanted in 2020.The patient recently started experiencing dysphagia had a dilation performed.During surgery abscess were observed with puss.The device was removed.

Manufacturer Narrative

(b)(4).Date sent: 12/4/2023.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 tooling marks were observed 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 24128 number, and no non-conformances related to the malfunction were identified.

• 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 ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 18031257
• MDR Text Key: 326912523
• Report Number: 3008766073-2023-00213
• 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
• Report Date: 12/04/2023

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: 11/21/2022
• Device Catalogue Number: LXMC14
• Device Lot Number: 24128
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/18/2023
• Initial Date FDA Received: 10/30/2023
• Supplement Dates Manufacturer Received: 11/14/2023
• Supplement Dates FDA Received: 12/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/21/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention