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

Catalog Number UNK LINX MAGNETIC IMPLANT

Device Problem Material Erosion (1214)

Patient Problems Erosion (1750); Dysphagia/ Odynophagia (1815); Obstruction/Occlusion (2422); Abdominal Distention (2601); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).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: multi-institutional outcomes using magnetic sphincter augmentation versus nissen fundoplication for chronic gastroesophageal reflux disease.Author/s: heather f.Warren, jessica l.Reynolds, john c.Lipham, joerg zehetner, nikolai a.Bildzukewicz, paul a.Taiganides, jody mickley, ralph w.Aye, alexander s.Farivar, brian e.Louie.Citation: surg endosc (2016) 30:3289¿3296; doi 10.1007/s00464-015-4659-y.This is a multi-institutional retrospective cohort study of patients with gerd undergoing magnetic sphincter augmentation (msa) or nissen fundoplication (nf).Between 06 apr 2007 to 12 december 2014, 415 patients underwent either msa of nf for the treatment of chronic gerd.Msa group were 201 patients (male=52%, female=48%; age range 42-64 years, mean age=54 years; bmi=32).Msa implantation was completed using the linx reflux management system (ethicon).Reported complications included gastroesophageal junction (gej) obstruction (n=1) which required to return to the operating room for removal of a crural stitch; failure to control reflux (n=1) at 13 months postoperatively which the patient was converted from msa to nf; device erosion with persistent dysphagia (n=1) 20 months after implantation.Persistent dysphagia was demonstrated a portion of the magnetic sphincter within the esophageal lumen.This was removed by cutting the exposed magnetic beads.Serial endoscopies demonstrated complete healing of the erosion without any further complication.1-year post-operative complaint included mild gas bloat (n=27%); moderate gas bloat (n=14%); severe gas bloat (n=5%); mild dysphagia (n=44%); moderate dysphagia (n=13%); severe dysphagia (n=1%).In conclusion, msa for uncomplicated gerd achieves similar improvements in quality of life and symptomatic relief, with fewer side effects, but lower ppi elimination rates when compared to propensity-matched nf cases.

• 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: 9013346
• MDR Text Key: 161089976
• Report Number: 3008766073-2019-00448
• 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