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); Patient Device Interaction Problem (4001)

Patient Problems Dysphagia/ Odynophagia (1815); Pyrosis/Heartburn (1883); Hypersensitivity/Allergic reaction (1907); Pocket Erosion (2013); Hernia (2240); Abdominal Distention (2601)

Event Date 01/18/2022

Event Type  Injury  

Event Description

Title: s148: long-term patient-reported outcomes of laparoscopic magnetic sphincter augmentation versus nissen fundoplication: a 5-year follow-up study.Author(s): sean m.O¿neill · anahita d.Jalilvand · jennifer s.Colvin · kelly r.Haisley · kyle a.Perry.Citation: surgical endoscopy (2022) 36:6851¿6858; https://doi.Org/10.1007/s00464-022-09015-1.This study hypothesized that the long-term patient-reported outcomes of magnetic sphincter augmentation (msa) would be similar to those achieved with laparoscopic nissen fundoplication (lnf).Between march 2013 and july 2015, 70 patients undergoing primary msa or lnf for the management of symptomatic gastroesophageal reflux disease (gerd) were included in the study.There were 25 patients (mean age 51.6 years, mean bmi 27.1 kg/m2, and 52 percent were females) who underwent msa using the linx (ethicon endo-surgery) device.There were 45 patients who underwent lnf using unknown manufacturer devices.For both msa and lnf, a circumferential esophageal and mediastinal dissection was performed to achieve 3 cm of intra-abdominal esophagus, with reduction of any hiatal hernia if present.Cruroplasty was performed routinely with interrupted braided nonabsorbable polyester suture (manufacturer: unknow), using pledgets only during lnf cases.Msa patients were fed a regular diet immediately with the expectation of same-day discharge, and lnf patients were advanced to a full liquid diet prior to discharge on postoperative day 1.The reported complications included recurrent hiatal hernia (n=1), persistent bloating at 22 months (n=1), erosion at 45 months (n=1), dysphagia with recurrent reflux at 60 months (n=1), and perceived nickel allergy at 8 months, despite the satisfactory resolution of reflux symptoms (n=1).In conclusion msa appears to offer similar long-term improvement in disease-specific quality of life as lnf.For msa, there was a trend toward reduced long-term bloating compared to lnf, but need for reoperation and device removal may be associated with patient dissatisfaction.

Manufacturer Narrative

(b)(4).Date sent: 7/3/2023.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.

• 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: 17247370
• MDR Text Key: 318292224
• Report Number: 3008766073-2023-00122
• 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: 07/03/2023

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
• Initial Date Manufacturer Received: 06/26/2023
• Initial Date FDA Received: 07/03/2023
• 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