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

Catalog Number UNK LINX MAGNETIC IMPLANT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Chest Pain (1776); Dysphagia/ Odynophagia (1815); Vomiting (2144); Obstruction/Occlusion (2422); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date of event: unknown.(b)(4).The lot was not provided; therefore, the manufacturing records could not be reviewed.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.

Event Description

It was reported via journal article: title: short-term outcomes using magnetic sphincter augmentation versus nissen fundoplication for medically resistant gastroesophageal reflux disease.Authors: brian e.Louie, md, alexander s.Farivar, md, dale shultz, bs, christina brennan, ccrp, eric vallieres, md, and ralph w.Aye, md.Citation: ann thorac surg (2014); 98:498¿505.Doi: http://dx.Doi.Org/10.1016/j.Athoracsur.2014.04.074.The authors evaluated their experience with magnetic sphincter augmentation (msa) and compared it with laparoscopic nissen fundoplication (lnf) at 6 months.A retrospective case-control study was performed on 34 consecutive patients (msa group; 18 male and 16 female; mean age:54 ±11.8 years; bmi: 27 ±5.1 kg/m2) who underwent laparoscopic implantation of a magnetic sphincter for chronic gastrointestinal esophageal disease (gerd) and a hiatal hernia of less than 3 cm from september 2012 to december 2013.For comparison, a review of 32 patients (lnf group; 13 male and 19 female; mean age: 47±12.2; bmi:30±4.4 kg/m2), who underwent laparoscopic nissen fundoplication (lnf), that were identified from a prospectively maintained benign esophageal surgical database from january 2010 to july 2013.During lnf, once a 3cm of intraabdominal esophagus was established, the esophageal hiatus was closed with single ¿0¿ polyester sutures (ethicon).In magnetic sphincter augmentation (msa), the appropriately sized linx device (ethicon) was situated in the tunnel and around the esophagus, and the sutures were secured using a suture-securing device.Reported complications in the lnf group included esophageal obstruction (n-1) in which a suture was removed from the hiatal closure and was discharged without further sequelae, swallowing ability worsened at 6 weeks (n-?), symptomatic esophageal spasms (n-2) requiring medical therapy, and esophagitis (n-1).Reported complications in the msa group included swallowing ability worsened at 6 weeks (n-?), food bolus impaction (n-1) requiring evaluation, but no invasive treatment, dysphagia (n-1) in which the patient underwent endoscopic balloon dilation, esophagitis with an elevated demeester score (n-4), heart burn (n-3), regurgitataion (n-6), cough (n-27), aspiration (n-28), and chest pain (n-25).In conclusion, msa results in similar objective control of gerd, symptom resolution, and improved quality of life compared with lnf.Msa seems to restore a more physiologic sphincter that allows physiologic reflux, facilitates belching, and creates less bloating and flatulence.This device has the potential to allow individualized treatment of patients with gerd and increase the surgical treatment of gerd.

• Brand Name: UNK LINX MAGNETIC IMPLANT
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• Manufacturer Contact: milt garrett ; 4188 lexington avenue north; shoreview, MN
• MDR Report Key: 9005851
• MDR Text Key: 161088626
• Report Number: 3008766073-2019-00442
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/15/2019

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/15/2019
• Initial Date FDA Received: 09/12/2019
• 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