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); Pain (1994)

Event Date 01/01/2023

Event Type  Injury  

Event Description

Title: the impact of magnetic sphincter augmentation (msa) on esophagogastric junction (egj) and esophageal body physiology and manometric characteristics.Author(s): shahin ayazi, md, katrin schwameis, md, ping zheng, md, kirsten newhams, md, brittney m.Myers, ms, andrew d.Grubic, do, toshitaka hoppo, md, and blair a.Jobe, md.Citation: ann surg 2023;277:e545¿e551; doi: 10.1097/sla.0000000000005239.The objective of the study is to evaluate the impact of magnetic sphincter augmentation (msa) on lower esophageal sphincter (les) and esophageal body using high resolution impedance manometry.Between march, 2012 and march, 2018, the first 100 patients who underwent msa and completed 1-year follow-up including high resolution impedance manometry, esophageal ph monitoring, upper endoscopy and standardized questionnaires were included in the study.There were 38 males and 62 females with a mean age of 55 years (range, 23-84 years) and a mean bmi of 28.9 kg/m2.The linx reflux management system (ethicon endo-surgery) was utilized for the msa procedure.During postoperative clinic visits at 6 months and then annually, patients were asked to complete standardized questionnaires including the gerd health-related quality of life and reflux symptom index (rsi).Further, postoperative gastrointestinal symptoms and proton pump inhibitor intake were assessed.The frequency and severity of persistent postoperative dysphagia was reported based on the rsi ¿difficulty swallowing¿ item and significant dysphagia was defined as a score =3.The reported complications included persistent dysphagia (rsi difficulty swallowing score =3) after surgery (n=15), and chest pain (n=4).In conclusion, magnetic sphincter augmentation results in improvement in the lower esophageal sphincter manometric characteristics.Although the device results in an increased outflow resistance at the esophagogastric junction, the compensatory increase in the force of esophageal contraction will result in unaltered esophageal peristaltic progression and bolus clearance.

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: 17247699
• MDR Text Key: 318298924
• Report Number: 3008766073-2023-00127
• 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

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