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

Catalog Number UNK LINX MAGNETIC IMPLANT

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Arrhythmia (1721); Myocardial Infarction (1969); Urinary Retention (2119); Urinary Tract Infection (2120); Insufficient Information (4580)

Event Date 08/25/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Publication year of 2020.(b)(4).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.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.What are the specific intraoperative complications (n=3) reported for the non-iem group? 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: patients with ineffective esophageal motility benefit from laparoscopic antireflux surgery.Author: alex addo, philip george, h.Reza zahiri, adrian park.Citation: not reported.Doi: https://doi.Org/10.1007/s00464-020-07951-4.This single-institution, retrospective review aims to analyze and compare qol outcomes following lars among patients with and without ineffective esophageal motility (iem).From january 2012 to july 2019, 203 patients (75.4% female) underwent laparoscopic antireflux surgery (lars) and were divided into two groups based on patients peristalsis: ineffective esophageal motility (iem) (n=44, male n=8, female n=36, age 58.1 ¿ 15.3, bm 27.4 ¿ 4.1) and non-iem (n=159, male n=42, female n=117, age 62.2 ¿ 12, bmi 28.2 ¿ 4.9).Patients in non-iem group who did not receive either partial or completer fundoplication, received either linx (ethicon) or gatstropexy alone.In the non-iem group, unspecified intraoperative complications (n=3) was reported.Arrhythmia (n=1), urinary retention (n=1), prolonged ileus (n=1), urinary tract infection (n=2), myocardial infarction (n=1), reoperation (n=4) and recurrence (n=1) were reported as post-operative complications.Patients with ineffective esophageal motility derive significant benefits in perioperative and qol outcomes after lars.Nevertheless, as anticipated, their baseline dysmotility may reduce the degree of improvement in dysphagia rates post-surgery compared to patients with normal motility.Furthermore, the presence of preoperative iem should not be a contraindication for complete fundoplication.Key to optimal outcomes after lars is careful patient selection based on objective perioperative data, including manometry evaluation, with the purpose of tailoring surgery to provide effective reflux control and improved esophageal clearance.

Manufacturer Narrative

(b)(4).Date sent: 4/14/2021.H11: corrected data = h10; unspecified intraoperative complications (n=3) this information was omitted on the previous report.

• Brand Name: UNK LINX MAGNETIC IMPLANT
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 11568160
• MDR Text Key: 255417492
• Report Number: 3008766073-2021-00047
• 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
• Type of Report: Initial,Followup
• Report Date: 03/08/2021

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK LINX MAGNETIC IMPLANT
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/08/2021
• Initial Date FDA Received: 03/25/2021
• Supplement Dates Manufacturer Received: 04/14/2021
• Supplement Dates FDA Received: 04/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention