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)

Event Date 01/01/2024

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 4/10/2024.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.

Event Description

It was reported via journal article: title: impact of change in sizing protocol on outcome of magnetic sphincter augmentation authors: inanc s.Sarici, sven e.Eriksson, ping zheng, olivia moore, blair a.Jobe, shahin ayazi.Citation: annals of surgery publish ahead of print doi:10.1097/sla.0000000000006249.Between april 2013 and august 2021, a total of 604 patients (225 male and 379 female) with a mean age of 57 years were included in the study.These patients underwent magnetic sphincter augmentation (msa) divided into two groups according to the implanted device's size (above sizing); pop+2 group (pop-off point +2 beads) consisting of 388 patients, and pop+3 group (pop-off point +3 beads) with 216 patients.The msa procedure was completed laparoscopically and consisted of complete reduction and excision of hiatal hernia sac if indicated, complete circumferential mediastinal dissection of the esophagus and restoration of at least 3 cm intraabdominal esophageal length in all patients.A small tunnel was created between the posterior vagal nerve trunk and esophagus at the level of gastroesophageal junction to place the device linx¿ magnetic sphincter augmentation device (ethicon).The mean folllow-up for all patients was 14.2 months.Reported complications include; (n=5) reflux symptoms and (n=61) persistent dysphagia in pop+2 group, and (n=3) reflux symptoms, and (n=35) persistent dysphagia in pop+3 group.Conclusions: upsizing from pop+2 to pop+3 does not reduce dysphagia or affect other msa outcomes; however, patients with poor peristalsis or hypercontractile esophagus do benefit.Regardless of sizing protocol, preoperative clinical characteristics varied among device sizes, suggesting size is not a modifiable factor, but a surrogate for esophageal circumference.

• 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: 19078813
• MDR Text Key: 339813084
• Report Number: 3008766073-2024-00057
• 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: 04/10/2024

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: UNK LINX MAGNETIC IMPLANT
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/27/2024
• Initial Date FDA Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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