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); Inflammation (1932); Nausea (1970); Pain (1994); Vomiting (2144); Abdominal Distention (2601); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 10/04/2019.Date of event: unknown.(b)(4).The lot was not provided; therefore, the manufacturing records could not be reviewed.

Event Description

It was reported via journal article: title: pseudoachalasia following magnetic sphincter augmentation with recovery of peristalsis following dilation: a case report.Author : ayazi s.; salvitti m.; hoppo t.; gonzalez m.; zaidi a.H.; jobe b.A.Citation: n engl j med 368;8; february 21, 2013; doi: 10.1056/nejmoa1205544.The objective of the prospective, multicenter, single-group study was to evaluate safety and effectiveness of a new magnetic device to augment the lower esophageal sphincter.The study was designed as a 5-year prospective, multicenter, single-group evaluation of magnetic sphincter device.Between january and september 2009, 100 patients were enrolled in the study (52% male; 48% female; age range 18-75 years; median bmi 28 range 20-35), had at least a 6-month history of gastroesophageal reflux disease (gerd) and had a partial response to daily proton-pump inhibitors, with increased exposure to esophageal acid as confirmed by ph monitoring.Reported complications included mild dysphagia (n=47), moderate dysphagia (n=16), severe dysphagia (n=5) in which 3 patients had required removal of the device at 21, 31, and 93 days after implantation and had the event resolved, further 19 patients underwent esophageal dilation with 16 reporting improvement after the procedure; nausea (n=1) and vomiting (n=1) which the patients required rehospitalization 2 days after surgery, their symptoms resolved with conservative therapy.The device was then removed as part of the disease management at 489 days and 1062 days respectively post implantation; mild bloating (n=12), moderate bloating (n=2); mild pain (n=7), moderate pain (n=13), severe pain (n=5), which required device removal in 1 patient; mild odynophagia (n=4), moderate odynophagia (n=3), severe odynophagia (n=1); mild hiccups (n=7), moderate hiccups (n=1); mild nausea (n=3), moderate nausea (n=2), severe nausea (n=2); mild inability to belch or vomit (n=5), moderate inability to belch or vomit (n=1); mild decreased appetite (n=4); mild flatulence (n=2); mild belching (n=2); mild weight loss (n=2); moderate food impaction (n=1); mild globus sensation (n=1); mild irritable bowel syndrome or dyspepsia (n=1); moderate regurgitation of sticky mucus (n=1); mild uncomfortable feeling in chest (n=1); moderate vomiting (n=1); moderate persistent gerd (n=1); grade a esophagitis (n=3) developed at 1 year, grade a esophagitis (n=4) developed at 2 years, grade d esophagitis (n=1) develop at 1 year but showed complete resolution of esophagitis at 2 years.It was reported in the article that the mild intensity was defined as an awareness of signs or symptoms that did not interfere with usual activities, moderate as discomfort intense enough to cause interference with usual activities, and severe as incapacitating discomfort, with inability to perform work or usual activities.In conclusion, the single-group evaluation of 100 patients before and after sphincter augmentation with a magnetic device, exposure to esophageal acid decreased, reflux symptoms improved, and use of proton-pump inhibitors decreased.Clinical data clearly showed that the patients had heartburn symptoms despite ppi therapy, which resolved after magnetic augmentation.Follow-up studies are needed to assess long-term safety.

Event Description

It was reported via journal article: "title: pseudoachalasia following magnetic sphincter augmentation with recovery of peristalsis following dilation: a case report.Authors: ayazi s.; salvitti m.; hoppo t.; gonzalez m.; zaidi a.H.; jobe b.A.Citation: gastroenterology.Conference: 2019 ddw.United states.156 (6 s1) (pp s-1442), 2019 this report aimed to present a case of pseudoachalasia that occurred 14 months after magnetic sphincter augmentation (msa) and resolved with endoscopic dilation.A 54-year-old man with longstanding gastroesophageal reflux disease (gerd) underwent hiatal hernia repair and msa using a size 15 linx device (ethicon).The surgery was uneventful, and he was discharged on the same day.Few days after surgery, the patient was complaining of chest pain and dysphagia which were completely resolved with adherence to post-linx diet consisted of frequent small meals and a short course of steroid.Fourteen months after surgery, he complained of progressive dysphagia, but with normalization of distal esophageal acid exposure after objective evaluation.His high-resolution manometry (hrm) showed complete aperistalsis in the esophageal body and 0% bolus clearance on impedance analysis and a non-relaxing les with elevated integrated relaxation pressure (irp) of 21.2 mmhg.Videoesophagram showed a poor relaxation of the gastroesophageal junction (gej) with hold up of the liquid barium contrast above the gej.Patient underwent an egd which showed a moderate degree of tightness at gej, which was dilated using 57 and 60 french savory dilators.He had partial relief of his dysphagia after this procedure.Eight weeks later, he underwent another egd and dilation with 18-20 mmhg balloon with complete resolution of his dysphagia.A follow up hrm showed restoration of peristaltic esophageal contractions with normal mean amplitude and distal contractile integral (dci) and a completely relaxing les with normalization of irp and normal intrabolus pressure.Patient has remained free of symptom of dysphagia since then.Magnetic sphincter augmentation is increasing gej outflow resistance.This increase in the resistance, in this case led to outflow obstruction resulting aperistalsis and pseudoachalasia.Endoscopic dilation resolved the dysphagia and restored the peristaltic function of the esophagus.".

Manufacturer Narrative

(b)(4).

• 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: 9156855
• MDR Text Key: 163190227
• Report Number: 3008766073-2019-00518
• 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: literature
• Type of Report: Initial,Followup
• Report Date: 09/20/2019

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: 09/20/2019
• Initial Date FDA Received: 10/04/2019
• Supplement Dates Manufacturer Received: 11/08/2019
• Supplement Dates FDA Received: 11/14/2019
• Patient Sequence Number: 1