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 Abscess (1690); Arrhythmia (1721); Dysphagia/ Odynophagia (1815); Dyspnea (1816); Fatigue (1849); Pyrosis/Heartburn (1883); Hypersensitivity/Allergic reaction (1907); Nausea (1970); Pain (1994); Paresis (1998); Pneumonia (2011); Vomiting (2144); Hernia (2240); Respiratory Failure (2484)

Event Date 01/29/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Publication year of 2020.Infections.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 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

It was reported via journal article: title: clinical outcomes and predictors of favorable result after laparoscopic magnetic sphincter augmentation: single-institution experience with more than 500 patients.Authors: shahin ayazi, md, ping zheng, md, ali h zaidi, md, kristy chovanec, bs, madison salvitti, ms, kirsten newhams, md, toshitaka hoppo, md, blair a jobe, md, facs.Citation: surg endosc (2019) 33:s485¿s781.Https://doi.Org/10.1016/j.Jamcollsurg.2020.01.026.This retrospective study aims to evaluate the outcomes of msa in a large cohort of patients with gerd and to determine the factors predicting favorable outcomes.Between june 2013 and september 2018.,a total of 553 patients (211 males, 342 females) who were 18 years or older with gerd or laryngopharyngeal reflux symptoms despite being prescribed maximal antisecretory therapy and underwent laparoscopic magnetic sphincter augmentation (msa) were included in this study.During the procedure, the linx device (ethicon) was used.The implant procedure is performed laparoscopically and consists of complete posterior mediastinal esophageal mobilization with restoration of intra-abdominal esophageal length (3 cm) and interrupted posterior crural closure (without pledgets or mesh).The device placement is at the level of the gej with the posterior vagus nerve trunk located on the outside of the magnetic ring.A ¿minimal dissection¿ technique was used in patients with little to no hh during the beginning of procedure employment.Follow up was done at a mean of 10.3 (10.6) months after msa.Reported complications included :there were only 2 major complications, co2 retention requiring reintubation (n =1), mediastinal abscess requiring drainage and iv antibiotic (n=1), minor complications were observed in the patients: poor postoperative pain control (n = 4),significant nausea during immediate postoperative period (n = 5), abdominal pain requiring additional evaluation (n =5), bothersome nausea or vomiting requiring emergency department visit (n=11), lethargy (n =3), dysphagia requiring hospital admission (n = 7), dyspnea requiring additional workup (n = 2), aspiration pneumonia (n =1) cardiac arrhythmia (n = 1), need for supplemental oxygen (n=7).Thirsty-seven patients required removal of their device indicated by a clinical reason.Of these, 20 removals were due to significant dysphagia or chest pain, worsening typical reflux symptoms (n=4), worsening atypical reflux symptom (n= 3), possible titanium allergy (n=1) , unexplained leukocytosis (n=1), need for subsequent operation (n=2), pseudoachalsia not responding to dilation was observed (n=1), gastrectomy for severe gastroparesis (n=1),recurrence of hernia and mediastinal abscess (n=1), readmittion within 30 days from operation (n=23) readmittion within 90 days from operation (n=8) one patient was readmitted 3 times;this patient required 2 admissions for persistent nausea and vomiting.Two patients required 2 readmissions.70 patients required more than 1, dilation for bothersome dysphagia or chest pain.2 patients, the device was found to be discontinuous and required explantation, neither of these 2 patients was symptomatic and disconnection was found on the imaging obtained for other reasons.Recurrence of hernia and migration of the device (n=3), removal indicated by device malfunction (n=2), and disconnected device (n=2).It was concluded, that msa implantation is associated with very good clinical and objective outcomes in gerd patients.Age younger than 45 years, male sex, gerd-hrql total score 15, and abnormal demeester score are the 4 preoperative factors predicting favorable outcomes and can be used in preoperative counseling and patient selection.

• 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 55126 ; 6107428552
• MDR Report Key: 11574263
• MDR Text Key: 242400490
• Report Number: 3008766073-2021-00054
• 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: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/09/2021

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: 03/09/2021
• Initial Date FDA Received: 03/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention