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

Catalog Number UNK LINX MAGNETIC IMPLANT

Device Problems Material Erosion (1214); Appropriate Term/Code Not Available (3191); Patient Device Interaction Problem (4001)

Patient Problems Erosion (1750); Dysphagia/ Odynophagia (1815); Pyrosis/Heartburn (1883); Pain (1994); Vomiting (2144); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Publication year of 2020.This report is related to a journal article, therefore, no product will be returned for analysis and the manufacturing records cannot be reviewed as the lot/batch number has not been provided.

Event Description

It was reported via journal article: title, 'six to 12-year outcomes of magnetic sphincter augmentation for gastroesophageal reflux disease'.Authors: david e.Ferrari, emanuel e.Asti, veronica lazzari, stefano siboni, daniele bernardi & luigi bonavina.The magnetic sphincter augmentation (msa) device has been proven safe and effective in controlling typical reflux symptoms and esophageal acid exposure for up to 6-year follow-up.Longer term outcomes have not been reported yet.A prospectively maintained database was reviewed to assess long-term safety and efficacy of the laparoscopic msa procedure at a single referral center.Gastro - esophageal reflux disease-health related quality of life (gerd-hrql), use of proton-pump inhibitors (ppi), and esophageal acid exposure were compared to baseline.Favorable outcomes were defined as = 50% improvement of gerd-hrql total score and ppi discontinuation.Between march 2007 and march 2020, 335 patients met the study inclusion criteria, and 124 of them were followed from 6 to 12 years after surgery (median 9 years, iqr 2).Mean total gerd-hrql score significantly improved from 19.9 to 4.01 (p < 0.001), and ppi were discontinued by 79% of patients.The mean total percent time with ph < 4 decreased from 9.6% at baseline to 4.1% (p < 0.001), with 89% of patients achieving ph normalization.Independent predictors of a favorable outcome were age at intervention < 40 years (or 4.17) and gerd-hrql score > 15 (or 4.09).We confirm long-term safety and efficacy of msa in terms of symptom improvement, decreased drug dependency, and reduced esophageal acid exposure.Adverse events were assessed from the time of implant through to the final visit.The rate of procedure-related adverse events was 11.6% (39/335) throughout the overall study period: eight patients (2.4%) required a single endoscopic pneumatic dilation due to persistent dysphagia at 11, 13, 21, 23, 28, 53, 60, and 65 months, respectively, after surgery.Thirty-one patients (9.2%) required laparoscopic device removal for various reasons ( erosion, regurgitation, heartburn, dysphagia, foreign body sensation, odynophagia, pharyngodynia, chronic cough, need of magnetic resonance study).Two patients died during the follow-up for unrelated reasons (no adverse events).

• 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: kara ditty-bovard ; 4188 lexington avenue north; shoreview, MN ; 6107428552
• MDR Report Key: 10661543
• MDR Text Key: 215266595
• Report Number: 3008766073-2020-00152
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/14/2020

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?: No
• 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: 09/14/2020
• Initial Date FDA Received: 10/12/2020
• 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
• Patient Outcome(s): Required Intervention