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 Device Interaction Problem (4001)

Patient Problems Dysphagia/ Odynophagia (1815); Inflammation (1932); Nausea (1970); Pain (1994); Vomiting (2144); Abdominal Distention (2601); Paresthesia (4421); Cramp(s) /Muscle Spasm(s) (4521); Insufficient Information (4580)

Event Date 12/06/2022

Event Type  Injury  

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.

Event Description

Title: feasibility and efficacy of magnetic sphincter augmentation for the management of gastroesophageal reflux disease post-sleeve gastrectomy for obesity authors: leena khaitan, michael hill, michael michel, patrick chiasson, philip woodworth, reginald bell, ragui sadek, aaron hoffman, kari loing, paula veldhuis, william petraiuolo, carlos anciano citation cite: obesity surgery (2023) 33:387¿396.Https://doi.Org/10.1007/s11695-022-06381-6 the principal aim of this investigational device exemption (ide) study was to evaluate the safety and efficacy of magnetic sphincter augmentation (msa) in patients who had previously undergone laparoscopic sleeve gastrectomy (lsg).This prospective, post-market, single-arm, multi-site observational study was conducted from december 1, 2017, to june 8, 2021, at 12 us institutions.Thirty subjects who underwent msa implantation were followed 12 months post-implant.The study population consisted of 90.0% female with a mean age of 47.1 years with an average baseline bmi of 29.9 kg/m2.The mean length of time between lsg and msa implantation was 3.2 years.Devices used include dermabond and the linx reflux management system (torax medical, inc., shoreview, mn, part of the johnson & johnson family of companies).The distribution of linx device size was 15 beads (40.0%), followed by 16 beads (26.7%), 17 beads (23.3%), and 14 bead device (10.0%).Complications mentioned for dermabond was hypersensitivity while the complications for linx device were dysphagia, pain, nausea, vomiting, esophageal spasm, epigastric pain and bloating, esophagitis, face tingling, foam pooling in throat.In conclusion, based on the 12-month results of this ide trial, which specially evaluated msa in a subject population who had achieved weight loss post-lsg, ppi use is significantly lower and even eliminated in most subjects.Regurgitation is also significantly reduced resulting in improved quality of life.Thus, msa appears to be safe and effective with comparable morbidity in the treatment of gerd in patients who previously underwent sleeve gastrectomy.

Manufacturer Narrative

(b)(4).Date sent: 7/17/2023.Additional information was requested, and the following was obtained: does the author/surgeon believe that the ethicon device (torax linx) caused or contributed to the patient complications mentioned in the article? if yes, please explain.Dysphagia (n=5).All 5 were listed as the following: ¿yes/probably/possibly.¿ all resolved without sequalae.(n=1) 17 days post implant underwent explant of device, and subject was followed 90 days post-explant and no aes reported.Subject had dysphagia with associated nausea and vomiting, ¿yes/probably/possibly.¿ all resolved without sequalae after explant.(n=1) 121 days post implant with conversion of sleeve to gastric bypass due to the subject¿s anatomy (dilated fundus) which caused dysphagia.Underwent explant of device and subject was followed 90 days post-explant and no aes noted.Removal occurred 121 days post-implant when conversion of sleeve to gastric bypass due to subject¿s anatomy (dilated fundus) causing dysphagia.The reason for explant was deemed not device and/or procedure related by the principal investigator.The device cannot be used in a gastric bypass.The device had to be removed.(n=1) with nausea and vomiting was re-admitted 8days post implant.After iv hydration and prednisone, the subject was discharged 4 days later.Symptoms however did not resolve, and the subject was eventually explanted.¿yes/probably/possibly.¿ resolved without sequalae after explant / 22 days after implant.Esophageal spasm (n=1).Treatment: not reported.¿yes/probably/possibly.¿ resolved without sequalae.Not explanted.Foam pooling in throat (n=1).Treatment: not reported.¿no/unlikely.¿ resolved without sequalae.Epigastric pain and bloating (n=1).Treatment: not reported.¿yes/probably/possibly.¿ resolved without sequalae.Pain in chest with nausea and vomiting (n=1).Treatment: not reported.¿yes/probably/possibly.¿ resolved without sequalae.Mild intensity esophagitis (n=1).Treatment: not reported, however, it was mentioned in the article that the adverse event (ae) was not deemed serious.¿unknown.¿ ongoing.Moderate intensity face tingling and pain (n=1).Treatment: not reported, however, it was mentioned in the article that the adverse event (ae) was not deemed serious.¿yes/probably/possibly.¿ resolved without sequalae.Pain (n=3).N=1.¿yes/probably/possibly.¿ resolved without sequalae.N=2.¿no/unlikely.¿ resolved without sequalae.Treatment: (n=1) hospitalization longer than 24h.This references same subject as above i.E.: (n=1) with nausea and vomiting was re-admitted 8days post implant.After iv hydration and prednisone, the subject was discharged 4 days later.Symptoms however did not resolve, and the subject was eventually explanted.¿yes/probably/possibly.¿ resolved without sequalae after explant.¿.

• 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: 17247647
• MDR Text Key: 318343887
• Report Number: 3008766073-2023-00125
• 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,Followup
• Report Date: 07/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2023
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/05/2023
• 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): Hospitalization; Required Intervention