MAUDE Adverse Event Report: TORAX MEDICAL, INC. LINX 1.5 16 BEAD US; ANTI-REFLUX IMPLANT

Catalog Number LXMC16

Device Problems Device Appears to Trigger Rejection (1524); Patient Device Interaction Problem (4001)

Patient Problems Dysphagia/ Odynophagia (1815); Pneumonia (2011); Weight Changes (2607)

Event Date 01/05/2024

Event Type  Injury  

Event Description

It was reported that a linx was implanted in 2020.The patient experienced satisfactory reflux symptoms for the first year and from 2021-2023 they started to experience worse dysphagia and it became unbearable for the patient up to the point where it led to malnourishment (around 20 lbs.) and aspiration pneumonia upon explant date (b)(6) 2024.

Manufacturer Narrative

(b)(4).Date sent: 1/18/2024.D6a: exact implant date is unk.Assumed first day of the month and first month of the year.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 was the exact implant take place? what is the product code for the linx device that was removed? 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 weight loss? besides the reported dysphagia and weight loss, 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.

Manufacturer Narrative

(b)(4) date sent: 4/1/2024 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.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, significant tooling marks were noted 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.

Manufacturer Narrative

(b)(4).Date sent: 2/29/2024.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? yes, testing was done.Patient had zero motility.What was the exact implant take place? unknown.What is the product code for the linx device that was removed? lxmc16.What is the lot number of the linx device? unknown.When using the linx sizing device what technique was used to determine the size? unknown did the patient have an autoimmune disease? unknown.Is the patient currently taking steroids / immunosuppressive drugs? unknown.Did the patient have any pre-existing dysphagia or other conditions (other than gerd)? unknown.How severe was the dysphagia/odynophagia before intervention? severe.Were there any intra-operative complications during implant? no.Was there any hiatal or crural repair done at the same time as the implant? unknown.Were there any other contributing factors that led to the removal of the device other than the reported dysphagia and weight loss? no.Besides the reported dysphagia and weight loss, what was the reason for removal of the linx device? just those.Was the device found in the correct position/geometry at the time of removal? yes.There is only one device on this complaint and the correct one is lxmc16.D1, d4.

• Brand Name: LINX 1.5 16 BEAD US
• 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: 18539539
• MDR Text Key: 333178920
• Report Number: 3008766073-2024-00015
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/01/2024

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: LXMC16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/05/2024
• Initial Date FDA Received: 01/18/2024
• Supplement Dates Manufacturer Received: 02/19/2024; 04/01/2024
• Supplement Dates FDA Received: 02/29/2024; 04/01/2024
• 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: 63 YR
• Patient Sex: Male