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

Catalog Number UNK LINX MAGNETIC IMPLANT

Device Problem Malposition of Device (2616)

Patient Problems Inflammation (1932); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 10/01/2019.Date of event: unknown.The lot was not provided; therefore, the manufacturing records could not be reviewed.

Event Description

It was reported via journal article: title: hiatal hernia recurrence following magnetic sphincter augmentation and posterior cruroplasty: intermediate-term outcomes.Authors: kais a.Rona1 ¿ james m.Tatum1 ¿ joerg zehetner3 ¿ katrin schwameis1 ¿ carol chow2 ¿ kamran samakar, adrian dobrowolsky ¿ caitlin c.Houghton ¿ nikolai bildzukewicz ¿ john c.Lipham.Citation: surgical endoscopy (2018) 32:3374¿3379; https://doi.Org/10.1007/s00464-018-6059-6.This retrospective cohort study reports intermediate-term outcomes and hernia recurrence rate after concomitant msa and hhr.Between may 2009 and december 2015, 53 patients (age range 40 ¿ 79 years, mean age 62.8 years; gender ratio f:m reported as 1.84:1; mean bmi 25.6 ± 7.5) underwent msa implantation with the linx reflux management system (ethicon) and repair of a hiatal hernia measuring at least 3 cm.Hiatus.Once the hiatal repair was completed, the external circumference of the gastroesophageal junction was measured and an appropriately sized linx device placed.Reported complications included mild (grade a or b) esophagitis (n=5.6%); and malpositioned msa device (n=1).The msa device was then removed and a conversion to a toupet fundoplication was performed.In conclusion, concomitant magnetic sphincter augmentation and hiatal hernia repair in patients with gastroesophageal reflux disease and a moderate-sized hiatal hernia demonstrates durable subjective reflux control and an acceptable hiatal hernia recurrence rate at 1- to 2-year follow-up.

• 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: 9141586
• MDR Text Key: 163000159
• Report Number: 3008766073-2019-00498
• 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: 09/18/2019

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: 09/18/2019
• Initial Date FDA Received: 10/01/2019
• 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