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); Patient Device Interaction Problem (4001)

Patient Problems Pulmonary Embolism (1498); Adult Respiratory Distress Syndrome (1696); Dehydration (1807); Dysphagia/ Odynophagia (1815); Pocket Erosion (2013)

Event Date 11/08/2021

Event Type  Injury  

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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: does the author/surgeon believe that the ethicon device caused or contributed to the patient complications mentioned in the article? if yes, please explain.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.

Event Description

Title: loosening the belt on magnetic sphincter augmentation indications: does body mass index matter? author: tayler j.James1 · jocelyn f.Burke2 · luke r.Putnam1 · jennifer pan1 · nikolai a.Bildzukewicz1 · reginald bell2 ·john c.Lipham1 citation: https://doi.Org/10.1007/s00464-021-08839-7.The objective of this study was to compare the effectiveness of msa for treatment of gerd in normal weight, overweight, and obese patients.A retrospective cohort study was performed of prospectively collected data for consecutive patients who underwent laparoscopic msa at three high-volume centers from 2016 to 2019.A total of 621 patients were identified: 156 (25%) in the bmi < 25 group, 251 (41%) in the bmi 25¿29.9 group, 158 (25%) in the bmi 30¿34.9 group, and 56 (9%) in the bmi > 35 group.The appropriately sized linx® device is then placed around the distal esophagus.Reported complications included dysphagia and dehydration ( n =?) , hiatal hernia recurrence (n=32), msa erosion (n=1), dilation (n=108).In conclusion, magnetic sphincter augmentation is safe and effective in improving gerd symptoms, reducing esophageal acid exposure, and preventing hiatal hernia recurrence, irrespective of patient bmi.Msa should be considered an acceptable treatment option for obese patients with gerd.

Manufacturer Narrative

(b)(4).Date sent: 7/19/2023.Additional information received: as per ethicon medical professional: (b)(6).Comments: yes.1.No association between linx and two patients required conversion to open for bleeding , pulmonary embolus and respiratory distress or atrial fibrillation can be established since linx was placed around the distal esophagus.Thus excluded.These events cannot be ruled out as a complaint.Ip-01775412 - linx: dysphagia and dehydration ( n =?).Treatment: readmission.Hiatal hernia recurrence (n=32).Treatment: revision operation.Msa erosion (n=1).Treatment: msa removal.Dilation (n=108).Treatment: not reported.

• 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: 17277149
• MDR Text Key: 318556300
• Report Number: 3008766073-2023-00136
• 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,Followup
• Report Date: 07/19/2023

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/26/2023
• Initial Date FDA Received: 07/07/2023
• Supplement Dates Manufacturer Received: 07/10/2023
• Supplement Dates FDA Received: 07/19/2023
• 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; Hospitalization