MAUDE Adverse Event Report: TORAX MEDICAL, INC. UNK LINX MAGNETIC IMPLANT; ANTI-REFLUX IMPLANT

Catalog Number UNK LINX MAGNETIC IMPLANT

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

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

Event Date 01/23/2023

Event Type  Injury  

Event Description

Title: removal of the magnetic sphincter augmentation device: an assessment of etiology, clinical presentation, and management.Authors: sven eriksson, katrin schwameis, shahin ayazi, toshitaka hoppo, ping zheng, blair a.Jobe.Citation cite: surgical endoscopy (2023) 37:3769¿3779.Https://doi.Org/10.1007/s00464-023-09878-y.The objective of the current study was designed to characterize the groups of patients who required device removal for recurrent gerd symptoms or persistent dysphagia despite no objective evidence of device erosion, displacement or disruption.Demographic, clinical, objective testing, and quality of life data obtained preoperatively, after implantation and following removal were compared between removal for dysphagia and gerd groups.Sub-analyses were performed comparing outcomes with and without an anti-reflux surgery (ars) at the time of removal.The clinical outcomes after device removal, and the necessity for further treatment of post-removal gerd symptoms were assessed.Based on the results, the authors proposed a treatment paradigm to assist with management of patients who are being considered for device removal.The retrospective review of prospectively collected data from patients who underwent magnetic sphincter augmentation (msa) between 2013 and 2021.Inclusion criteria were patients with an age of 18 years or older with no history of foregut surgery prior to msa, who underwent device removal for either persistent dysphagia or recurrent gerd symptoms and had at least 6 months post-removal follow-up.The linx® reflux management system (ethicon, johnson & johnson; shoreview, mn) was used for msa.All procedures were performed laparoscopically by experienced foregut surgeons using standardized surgical techniques a total of 40 patients underwent device removal, 31 patients (male: n=5, female: n=26) for dysphagia and 9 patients (male: n=4, female: n=5) for gerd.Device removal was performed laparoscopically.The outer fibrous capsule surrounding the linx device was opened with harmonic shears (ethicon, johnson and johnson, raritan, nj) or laparoscopic scissors and each anterior bead was sequentially freed of its capsular attachments.Complications include dysphagia, regurgitation and heartburn.In conclusion, msa removal outcomes are dependent on the indication for removal.Removal for dysphagia yields excellent outcomes regardless of anti-reflux surgery.Patients with persistent gerd had worse outcomes on all measures without ars.The authors propose a tailored approach to msa removal-based indication for removal.

Manufacturer Narrative

(b)(4).Date sent: 7/3/2023.This report is related to a journal article, therefore no product will be returned for analysis and the batch history records cannot be reviewed as the lot/batch number has not been provided.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: does the author/surgeon believe that the ethicon device caused or contributed to the patient complications mentioned in the article? if yes, please explain.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.

• Brand Name: UNK LINX MAGNETIC IMPLANT
• 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: 17247920
• MDR Text Key: 318440488
• Report Number: 3008766073-2023-00131
• 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: Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/03/2023

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 Catalogue Number: UNK LINX MAGNETIC IMPLANT
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/26/2023
• Initial Date FDA Received: 07/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention