MAUDE Adverse Event Report: TORAX MEDICAL, INC. 1.5T LINX, 13B; ANTI-REFLUX IMPLANT

Catalog Number	LXMC13
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Dysphagia/ Odynophagia (1815); Discomfort (2330)
Date of Event	04/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Date sent: 4/29/2024.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.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 or Problem Description
It was reported that a linx device was explanted due to dysphagia.It was noted by the surgeon that the size might have been too small and that the patient should not have received the linx due to the patient already experiencing dysphagia but may have had success if the device would have been larger.
Additional Manufacturer Narrative
(b)(4) date sent: 5/9/2024 d6a: exact date is unk.Assumed first month of the year and first day of the month.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? not sure on what date did the implant take place? over one year ago, done in georgia (different surgeon) on what date did the explant take place? on (b)(6) 2024.What is the lot number of the linx device? not sure when using the linx sizing device what technique was used to determine the size? not sure did the patient have an autoimmune disease? not sure is the patient currently taking steroids / immunosuppressive drugs? no did the patient have any pre-existing dysphagia or other conditions (other than gerd)? surgeon implied yes how severe was the dysphagia/odynophagia before intervention? above average for surgeon were there any intra-operative complications during implant? not sure was there any hiatal or crural repair done at the same time as the implant? not sure, surgeon implied yes were there any other contributing factors that led to the removal of the device other than the reported dysphagia? dysphasia #1 discomfort #2 besides the reported dysphagia, what was the reason for removal of the linx device? discomfort was the device found in the correct position/geometry at the time of removal? yes.
Additional Manufacturer Narrative
(b)(4).Date sent: 5/23/2024.No lot number was provided therefore a device history could not be done.
Additional Manufacturer Narrative
(b)(4) date sent: 6/7/2024 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, significant 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.

• Brand Name: 1.5T LINX, 13B
• Common Device Name: 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: 19200927
• Report Number: 3008766073-2024-00078
• Device Sequence Number: 8035106
• Product Code: LEI
• UDI-Device Identifier: 00855106005332
• UDI-Public: 00855106005332
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P100049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/07/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: LXMC13
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/24/2024
• Supplement Date Received by Manufacturer: 05/03/2024; 05/23/2024; 05/31/2024
• Initial Report FDA Received Date: 04/29/2024
• Supplement Report FDA Received Date: 05/09/2024; 05/23/2024; 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown