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

Catalog Number LXMC17

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

Patient Problems Dysphagia/ Odynophagia (1815); Pyrosis/Heartburn (1883); Vomiting (2144); Hernia (2240)

Event Date 11/20/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 1/2/2024.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 or batch 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, vomiting and recurrent gerds? besides the reported dysphagia vomiting and recurrent 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? 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 linx device was implanted on (b)(6) 2019 and explanted on (b)(6) 2023 the patient originally had a history of a sleeve gastrectomy.After her sleeve gastrectomy she developed worsening issues with gerd at the time did not want to consider revision to roux en y gastric bypass to manage her gerd.She opted to undergo linx placement.Following linx placement on (b)(6) 2019 the patient had significant improvement in her gerd symptoms.Around (b)(6) 2022 patient first complained of some symptoms of food getting stuck and some issues with regurgitation.She underwent an egd and balloon dilation across the linx on (b)(6) 2022 which temporarily resolved her symptoms.Around (b)(6) 2023 patient again presented with worsening gerd symptoms.Barium upper gi was performed which showed linx in good position, but patient was developing some esophageal dilation.Steroids were prescribed with minimal improvement.Patient continued to try and do dietary modification but symptoms worsened.She had regained a significant amount of weight due to immobilitiy issues, and her diabetes was worsening.Another egd was done on (b)(6) 2023 which showed the patient had now developed significant esophageal dilation and dysmotility and it was suspected there may be a recurrence of her hiatal hernia.It was felt the best option would be conversion to roux en y gastric bypass with removal of the linx due to the esophageal dysmotility.This surgery was performed on (b)(6) 2023 and the patient did well postoperatively without issue.Linx was removed without issue.There was a 4cm recurrence of the hiatal hernia that was repaired during the surgery.Hospital of linx implant: (b)(6) hospital.Troublesome symptoms began around (b)(6) 2022.Prior to explant patient underwent multiple egd¿s with dilation, multiple upper gi video esophagram studies.See event description above for dates.Testing did not show any discontinued linx device.Patient did not undergo mri since device implant.

Manufacturer Narrative

(b)(4).Date sent: 1/31/2024.

Manufacturer Narrative

(b)(4).Date sent: 2/15/2024.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 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.

• 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: 18426100
• MDR Text Key: 331868051
• Report Number: 3008766073-2024-00004
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005370
• UDI-Public: 00855106005370
• 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: 02/15/2024

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: LXMC17
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/16/2023
• Initial Date FDA Received: 01/02/2024
• Supplement Dates Manufacturer Received: 01/16/2024; 02/14/2024
• Supplement Dates FDA Received: 01/31/2024; 02/15/2024
• 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: 60 YR
• Patient Sex: Female
• Patient Weight: 126 KG