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); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 11/09/2023

Event Type  Injury  

Event Description

It was reported that a linx removal for re-think study patient: (b)(6).Linx was electively removed on (b)(6) 2023 due to issues the patient developed with worsening esophageal spasm and jackhammer esophagus following implant of the linx device.The linx was removed robotically without incident.Date of original implant was on (b)(6) 2023.Hospital of linx implant: methodist specialty and transplant hospital.Symptoms of esophageal spasm were first reported on (b)(6) 2023.She had a subsequent follow up on (b)(6) 2023 in which spasm was significantly worse and was affecting oral intake.Medical interventions: patient was started on valium for esophageal spasm and given a medrol dosepak after her first follow up appointment on (b)(6) 2023.Patient called back with worsening symptoms and inability to tolerate valium so she was transitioned to methocarbamol and levsin with no improvement.After esophageal spasm was worsening and patient began to struggle with oral intake then on (b)(6) 2023 she was started on peppermint oil and a calcium channel blocker and started on iv fluid infusions to prevent dehydration.She underwent a barium upper gi esophagram that showed the linx was in good position.The contrast completely cleared the linx after 3 peristaltic waves.Patient followed up on (b)(6) 2023 with ongoing issues with esophageal spasm and another medrol dosepak was prescribed.She followed up with her gastroenterologist who performed an egd and dilation of the linx which had no effect on the symptoms.He repeated esophageal manometry which showed multiple swallows with dci >8000 consistent with jackhammer esophagus.I discussed the case at length with her gastroenterologist on (b)(6) 2023 and we agreed that with the worsening jackhammer esophagus symptoms and her failure to respond to treatments she would likely require explant.We opted to give her another 6 weeks to see if the symptoms would improve.She underwent cardiac evaluation and clearance to ensure there was no cardiac component to her symptoms.That workup included ekg, echocardiogram, exercise stress test, and 72 hour halter monitor and no unusual events were found.Patient followed up on (b)(6) 2023 with minimal improvement in symptoms and requested to move forward with explant.Explant occurred on (b)(6) 2023.None of the testing showed a discontinued linx or any abnormality with the device its self.

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.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.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? 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 muscle spasms? besides the reported dysphagia and muscle spasms, 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: 2/5/2024.

Manufacturer Narrative

(b)(4) date sent: 2/13/2024 investigation summary 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.Link length and tensile force were found to meet the applicable specifications.Overall, no analysis conclusions relevant to the patient experience were found.A manufacturing record evaluation was performed for the finished device 27613 number, and no non-conformances related to the malfunction were identified.

• 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: 18425648
• MDR Text Key: 331859328
• Report Number: 3008766073-2024-00002
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005356
• UDI-Public: 00855106005356
• 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: 02/13/2024

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
• Device Lot Number: 27613
• 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: 01/23/2024; 02/12/2024
• Supplement Dates FDA Received: 02/05/2024; 02/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/24/2020
• 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: 46 YR
• Patient Sex: Female
• Patient Weight: 85 KG