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

Catalog Number UNK LINX MAGNETIC IMPLANT

Device Problems Device Appears to Trigger Rejection (1524); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Dysphagia/ Odynophagia (1815); Pyrosis/Heartburn (1883); Pain (1994); Paresis (1998); Vomiting (2144); Respiratory Failure (2484); Abdominal Distention (2601)

Event Date 09/29/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report is related to a journal article, therefore no product will be returned for analysis and the batch history records cannot be reviewed as the lot/batch number has not been provided.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Title: expanded indication for magnetic sphincter augmentation: outcomes in weakly acidic reflux compared to standard gerd patients authors: milena nikolic, aleksa matic, joy feka, lisa gensthaler, ivan kristo, bogdan osmokrovic, franz m.Riegler, berta o.Mosleh, sebastian f.Schoppmann citation: journal of gastrointestinal surgery (2021).Https://doi.Org/10.1007/s11605-021-05152-5 the aim of this retrospective review study of a prospectively collected clinical database was to evaluate the long-term postoperative outcomes of patients with preoperative weakly acidic/biliary reflux undergoing msa in a high-volume specialized reflux center.Between 2012 to 2020, a total of 268 patients who underwent magnetic sphincter augmentation (msa) for chronic gastroesophageal reflux disease were included in the study.Of these, 67 patients (36 male and 31 female; median age of 44 years; median bmi of 25) were found to have weakly acidic reflux, while 201 (137 male and 64 female; median age of 51 years; median bmi of 25.5) revealed acidic reflux in the preoperative 24-h impedance-ph-metry.Surgery was performed using the msa device (linx® reflux management system; torax medical, maple grove, mn).The median follow-up time for patients with weakly acidic reflux and acidic reflux was 24 months (iqr, 31) and 22 months (iqr, 24), respectively.Reported complications include gas bloating syndrome (n=16); inability to belch/vomit (n=?); heartburn (n=?); regurgitation (n=?); chronic cough/respiratory symptoms (n=?); rarely difficulties swallowing with solids only (n=68) and occasional difficulties swallowing with solids (n=30) which was successfully managed by endoscopic balloon dilatation in 3 patients; continued use of proton pump inhibitor postoperatively (n=10%); unclear pain in the chest area (n=2) requiring explant of the msa device.In conclusion, msa leads to a significant reduction in daily, bothersome gerd symptoms, with low postoperative morbidity and increase in gerd-related quality of life, as well as alimentary satisfaction in patients with weakly acidic reflux.Furthermore, the importance of a preoperative 24-h impedance-ph-metry in detecting patients with weakly acidic reflux, who would benefit from msa, should not be underestimated.

• 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 55126 ; 6107428552
• MDR Report Key: 13314023
• MDR Text Key: 284172163
• Report Number: 3008766073-2022-00018
• 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: Other
• Type of Report: Initial

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: 01/05/2022
• Initial Date FDA Received: 01/21/2022
• 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