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

Catalog Number UNK LINX MAGNETIC IMPLANT

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Dysphagia/ Odynophagia (1815); Blood Loss (2597); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 09/20/2019.Date of event: unknown.The lot was not provided; therefore, the manufacturing records could not be reviewed.Additional information was requested, and the following was obtained: does the surgeon believe that ethicon products involved caused and/or contributed to the post-operative complications described in the article? answer: the complication of prolonged dysphagia to the point of needing explantation were thought to be directly related to the device.Loose fitting seemed to contribute to improved rates of dysphagia.Does the surgeon believe there was any deficiency with the ethicon products used in this procedure? answer: there are not thought to be any deficiencies with the product itself however it does not seem to be as well tolerated over the long term as previously believed.

Event Description

Title: esophageal magnetic sphincter augmentation as a novel approach to post-bariatric surgery gastroesophageal reflux disease.Authors: john p.Kuckelman1 & cody j.Phillips1 & michael j.Derickson1 & byron j.Faler2 & matthew j.Mar.Authors: john p.Kuckelman; cody j.Phillips; michael j.Derickson; byron j.Faler; matthew j.Martin.Citation: obesity surgery (2018) 28:3080¿3086; https://doi.Org/10.1007/s11695-018-3292-y.The objective of this prospective study was to evaluate the safety and effectiveness of magnetic sphincter augmentation (msa) in patients with gastroesophageal reflux disease (gerd) after bariatric surgery and to compare outcomes among post bariatric patients undergoing msa versus the non-bariatric or ¿standard indications¿ msa cohort.Between september 2015 and february 2017, a total of 28 patients (male=14, female=14; mean age=43 years; mean bmi=28.1) were treated with msa (linx device; ethicon).During the procedure, operative time, blood loss, size of hiatal hernia when present, altered anatomy if encountered, and size of msa device placed were evaluated.Reported complications included prolonged dysphagia (n=4) in which one patient had required msa removal 4 months after msa placement due to severe dysphagia and three remaining patients were treated with endoscopy and dilation; and continued reflux (n=1).In conclusion, msa is a technically simple operation that offers a safe and highly effective new option for all patients with gerd.This procedure appears to exhibit a similar profile for patients who have previously undergone bariatric surgery, particularly sleeve gastrectomy.Prospective randomized studies will be necessary, but there is exciting potential for the role of msa in providing surgeons a new and much needed tool in their armamentarium against refractory or de novo gerd after bariatric procedures.

• 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: 9097981
• MDR Text Key: 162643038
• Report Number: 3008766073-2019-00467
• 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: Other
• Type of Report: Initial
• Report Date: 08/27/2019

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
• Initial Date Manufacturer Received: 08/27/2019
• Initial Date FDA Received: 09/20/2019
• 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