MAUDE Adverse Event Report: TORAX MEDICAL, INC. 1.5T LINX, 17 BEADS; ANTI-REFLUX IMPLANT

Model Number LXMC17

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Hernia (2240); Abdominal Distention (2601)

Event Date 06/21/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 7/5/2023 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)? 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? 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 during the lap hiatal hernia repair with linx removal the device was ineffective and causing bulging from consumption of food.

Manufacturer Narrative

(b)(4).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, tooling marks were observed in some bead cases and 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: 7/21/2023.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? 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)? 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? answer : -the patient was vetted properly and met requirements for linx placement.- the surgeon used pop + 3 sizing.- the patient received hiatal hernia repair.

• Brand Name: 1.5T LINX, 17 BEADS
• 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: 17261107
• MDR Text Key: 318557140
• Report Number: 3008766073-2023-00133
• 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: 08/08/2023

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 Model Number: LXMC17
• Device Catalogue Number: LXMC17
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/21/2023
• Initial Date FDA Received: 07/05/2023
• Supplement Dates Manufacturer Received: 07/14/2023; 08/08/2023
• Supplement Dates FDA Received: 07/21/2023; 08/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention