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

Catalog Number UNK LINX MAGNETIC IMPLANT

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Erosion (1750); Dysphagia/ Odynophagia (1815); Pain (1994); Foreign Body In Patient (2687); 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: esophageal penetration of the magnetic sphincter augmentation device: history repeats itself.Authors: renato salvador, md; mario costantini, md; giovanni capovilla, md; lino polese, md; and stefano merigliano, md.Citation: journal of laparoendoscopic & advanced surgical techniques; volume 27, number 8; 2017; doi: 10.1089/lap.2017.0182.This study discussed that the current gold standard surgical treatment for gastroesophageal reflux disease (gerd) is laparoscopic fundoplication which a device is implanted laparoscopically around the lower esophageal sphincter (les) to improve its barrier function and thus prevent gastroesophageal reflux.The authors reported two cases ((b)(6) year-old female patient and (b)(6) year-old male patient) of penetration of the esophageal lumen by magnetic sphincter augmentation device (msad; linx, ethicon).A (b)(6) year-old female patient underwent msad implantation 3 years earlier due to the presence of pathological gastroesophageal reflux complicated by barett¿s esophagus.The patient then reported severe and progressive dysphagia.She reported dysphagia further with solid food associated with epigastric pain during and after eating.She also noted of weight loss of 8 kg.It was reported that the upper endoscopy revealed three beads of the msad inside the esophageal lumen.She underwent ct scan of the chest and abdomen with an oral water-soluble contrast that revealed no leak or abscess.To clarify the exact position of the magnetic ring in relation to the esophagogastric junction, a barium swallow was also performed, which again showed no leakage from the gullet.The device was removed endoscopically using a double channel endoscope and an olympus endoloop cutter.After the procedure, a repeat barium swallow showed no signs of leakage.The patient was given a liquid diet, followed by the addition of soft food on the seventh day after the endoscopic procedure.The patient was thoroughly reexamined 2 months after the removal of her msad.Endoscopy showed complete healing of the esophageal mucosa, with no sign of esophagitis or stricture, and a hypotonic cardia.A (b)(6) year-old male patient had been implanted with msad 4 years earlier and reported bolus arrest (with meat) that resolved spontaneously on drinking some water.After the bolus arrest episode, the patient began to suffer from severe and progressive dysphagia.He also reported a weight loss of 8 kg.It was reported that the upper endoscopy revealed two beads inside the esophageal lumen.Ct scan of the chest and abdomen with gastrografin per os excluded any leak or abscess.The msad was removed endoscopically.A new water-soluble contrast swallow performed immediately after the procedure showed no sign of leakage.After 5 days, the patient resumed a liquid diet, adding soft food on the seventh day after the procedure.Ten weeks later, the patient has not complained of dysphagia.His gerd symptoms are well controlled by ppi therapy.In conclusion, msad implantation may be an effective way to control gerd, but the method can carry major complications, such as migration of the device into the esophagus.Endoscopic removal of a device possibly penetrating inside the esophagus is feasible and safe, and may later be followed up with a laparoscopic anti reflux procedure without any particular difficulty.

Manufacturer Narrative

(b)(4).Date sent: 11/19/2019.H10: corrected data - h6: removed device migration and added erosion.

• Brand Name: UNK LINX MAGNETIC IMPLANT
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 9152803
• MDR Text Key: 163127090
• Report Number: 3008766073-2019-00509
• Device Sequence Number: 1
• Product Code: LEI
• Combination Product (y/n): N
• PMA/PMN Number: P100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 09/19/2019

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: 09/19/2019
• Initial Date FDA Received: 10/03/2019
• Supplement Dates Manufacturer Received: 11/18/2019
• Supplement Dates FDA Received: 11/19/2019
• Patient Sequence Number: 1