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

Catalog Number UNK LINX MAGNETIC IMPLANT

Device Problems Migration or Expulsion of Device (1395); Device Appears to Trigger Rejection (1524); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Dysphagia/ Odynophagia (1815); Pain (1994); Pocket Erosion (2013)

Event Date 01/01/2021

Event Type  Injury  

Event Description

Title: a multicenter evaluation of factors associated with magnetic sphincter augmentation device removal.Author(s): jack p.Silva, charles hill, mark c.Wang, eddie a.Rodriguez, derek j.Yan, jessica wu, luke r.Putnam, caitlin c.Houghton, nikolai a.Bildzukewicz, f.P.Buckley, john c.Lipham.Citation: ssat abstracts s-1318, abstract 305.This study sought to analyze demographic and surgical variables which may influence magnetic sphincter augmentation device removal.Patients who underwent magnetic sphincter augmentation and subsequent device removal from 2013-2021 were included in the study.At one center, 750 linx (ethicon endo-surgery) magnetic sphincter augmentation devices were implanted of which 58 were removed.When including device removals from the second participating center, 79 patients underwent msa device removal.All removals were performed laparoscopically and at a mean time of 25 +/- 13 months after implantation.Removal patients were younger (56 vs 60 years) had smaller devices (14 vs 15 beads), longer implant operative time (77 vs 62 minutes) and were more likely to have autoimmune disease (21%vs 6%).The reported complications included a total of 79 device removals due to dysphagia (n=60%), chest pain (n=12%), erosion (n=5.2%) and other reasons (n=22%).In conclusion, the most common reason for removal is dysphagia followed by chest pain and very rarely for device erosion.In all cases, removal is safe and not associated with adverse outcomes.Patients with existing autoimmune disease, anxiety, or depression may have a higher likelihood of eventual device removal.Historical use of smaller msa devices associated with higher removal rates may explain recent practice changes to upsize by one bead size on initial device placement.

Manufacturer Narrative

(b)(4).Date sent: 7/7/2023.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.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: UNK LINX MAGNETIC IMPLANT
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4545 creek road; cincinnati OH
• Manufacturer Contact: kate karberg ; 4545 creek rd.; cincinnati, OH 45242 ; 3035526892
• MDR Report Key: 17277227
• MDR Text Key: 318565207
• Report Number: 3008766073-2023-00139
• 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,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2023
• 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
• Date Manufacturer Received: 06/26/2023
• 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