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); Pyrosis/Heartburn (1883)

Event Date 09/20/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 2/13/2024.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? 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 and gerds? besides the reported dysphagia and gerds, what was the reason for removal of the linx device? was the device found in the correct position/geometry at the time of removal? after implant, was the device initially effective in controlling reflux? 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 a patient is dealing with dysphagia and recurrent reflux symptoms.(b)(6) 2023 egd: c1m1, benign stricture at 35 dilated to 20mm.Gej bxs c/w nondysplastic barretts (b)(6) 2022 egd: c1m1 benign stricture dilated.Symptoms began (b)(6) 2022 testing did not reveal a discontinuous device.The patient did not undergo any mri.

Manufacturer Narrative

(b)(4).Date sent.2/22/2024.

Manufacturer Narrative

(b)(4).Date sent: 3/15/2024.Investigation summary: a suture wire knotted on a wire was observed during the visual assessment.It is known that sometimes, during the explant procedure, a suture is placed on the device to aid in the extraction of the device.Hence, it is presumed that the suture was placed by the explant facility during the explant procedure.A washer was noted to be disconnected from a bead case.The washer was observed to be bent outwards and weld tracks are visible on both the washer and bead case.These findings suggest that the washer was pulled out of the bead case due to external forces applied during an explant procedure.The remaining device characteristics, excepting the issues called out above, show no anomalies for a device that has been reasonably changed as part of the explant procedure and significant tooling marks were noted in some beads and washer.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, 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: 18697449
• MDR Text Key: 335297327
• Report Number: 3008766073-2024-00030
• Device Sequence Number: 1
• Product Code: LEI
• 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: Health Professional
• Reporter Occupation: Other
• Type of Report: Followup,Followup
• Report Date: 03/15/2024

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: LXMC15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/13/2024
• Supplement Dates Manufacturer Received: 02/16/2024; 03/15/2024
• Supplement Dates FDA Received: 02/22/2024; 03/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 66 KG