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 Dysphagia/ Odynophagia (1815); Pain (1994); Foreign Body In Patient (2687); Not Applicable (3189); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(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: favorable results from a prospective evaluation of 200 patients with large hiatal hernias undergoing linx magnetic sphincter augmentation.Authors: f.P.Buckley iii, reginald c.W.Bell, kate freeman, stephanie doggett, rachel heidrick.Citation: surg endosc (2018); 32:1762¿1768.Doi: https://doi.Org/10.1007/s00464-017-5859-4.The aim of this study is to prospectively evaluate the clinical effectiveness of magnetic sphincter augmentation (msa) in patients with larger hernias, including those with paraesophageal hernias, in whom an antireflux procedure would be performed routinely after herniorrhaphy.This multicenter, prospective study involves 200 consecutive patients (90 male and 110 female; age range: 21-93 years; mean bmi: 19-49 kg/m2) who were treated with magnetic sphincter augmentation (msa) at the time of repair of hiatal hernias > 3 cm between march 2014 to february 2017.Cruroplasty was performed with permanent suture until the hiatus was gently brought into apposition with the relaxed esophagus.Suture technique was simple 0-ethibond (ethicon) in 95 and simple 0-ethibond (ethicon) with 5 mm pledgets in 105 patients.After the hernia repair, the posterior vagus was elevated off the posterior esophagus and the msa sizer was introduced.The sizer was closed until it rested smoothly but noncompressively against the relaxed, non-distended esophagus.An linx msa device (ethicon) with a corresponding number of beads was then placed between the posterior esophagus and posterior vagus, reapproximated anteriorly, and the clasp actuated.The msa was positioned above the angle of his in all instances and preferably the device was placed cephalad to an intact first gastric branch of the posterior vagus.If the posterior vagus had been elevated for some distance, as occasionally occurred during dissection of a large hernia sac, a small polypropylene suture was placed from distal esophagus to perineurium of the posterior vagus distal to the msa device to provide posterior anchoring.The linx msa device (ethicon) was placed between the posterior vagus and the esophagus in all patients.Sixteen patients with a mobilized posterior vagus had a polypropylene suture placed anchoring the esophagus to the posterior vagus perineurium, thus creating a caudal delimiter for the msa.Reported complications included dysphagia/ dehydration (n-2) in which the patients were readmitted, chest pain (n-1) and linx msa device migrating to and fro about the hiatus (n-1) in which a laparoscopic surgery to reclose the hiatus above the msa was successfully performed and the patient is doing well 9 months postoperatively, persistent reflux and aspiration after the msa (n-1) in which the patient underwent successful conversion to fundoplication, and supradiaphragmatic linx all =< 2 cm axially (n-4) in which 1 patient underwent reoperation.In conclusion, this study resulted in favorable outcomes with median of 9 month follow-up.Comparing this to published reports of msa in patients with <3 cm hernias, the safety and clinical efficacy of msa are independent of initial hernia size.

• 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: 8994593
• MDR Text Key: 161085109
• Report Number: 3008766073-2019-00434
• 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: 08/14/2019

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: 08/14/2019
• Initial Date FDA Received: 09/11/2019
• 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