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

Catalog Number UNK LINX MAGNETIC IMPLANT

Device Problems Device Appears to Trigger Rejection (1524); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Dehydration (1807); Dysphagia/ Odynophagia (1815); Unspecified Infection (1930); Nausea (1970); Paresis (1998); Pneumonia (2011); Vomiting (2144); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 06/16/2023

Event Type  Injury  

Event Description

It was reported via journal article: title: the impact of delayed gastric emptying as measured by gastric emptying scintigraphy on the outcome of magnetic sphincter augmentation.Authors: sven e.Eriksson · ping zheng · inanc s.Sarici · xinxin shen · blair a.Jobe · shahin ayazi.Citation: surgical endoscopy (2023) 37:7144¿7152 https://doi.Org/10.1007/s00464-023-10190-y.The objective of this study is to evaluate the relationship between objective delayed gastric emptying (dge) and magnetic sphincter augmentation (msa) outcomes over time.Between 2013 and 2021, a total of 775 patients who underwent magnetic sphincter augmentation (msa).Patients with gerd who were 18 years or older with no history of prior foregut surgery who completed preoperative ges and had at least 1 year follow-up were included in this study.The median (iqr) age was 55.7 (44.9¿62.9) and bmi was 29.1 (26.8¿33.1).There were 26 (19.8%) patients with delayed gastric emptying (dge) and 105 patients with nge on gastric emptying scintigraphy (ges).During the initial 90 days after surgery 5 patients with dge and 3 patients with nge required readmission to the hospital.The indications for readmissions in dge group were severe dysphagia, complicated by poor oral intake and dehydration, all successfully managed with fluid resuscitation and endoscopic dilation (n=4) and surgical site infection (n=1).The indications for readmissions in the nge group were nausea and vomiting with dehydration, managed conservatively (n= 1), pneumonia (n=1) and severe esophageal spasm, which was managed with endoscopic dilation (n=1).The linx device (ethicon, johnson & johnson; shoreview, mn) is an expandable bracelet of titanium beads with magnetic cores that is placed around the esophagus at the esophagogastric junction (egj).The msa is manufactured in different sizes, ranging from 13 to 17 beads.A manufacturer provided sizing device that measures the circumference in number of beads is used to assist in the selection of the appropriately sized device.Reported complications included for dge/delayed gastric emptying (n=5); severe dysphagia, complicated by poor oral intake and dehydration, surgical site infection (n=1) and for nge/normal gastric emptying (n=3); nausea and vomiting with dehydration, pneumonia (n=1), severe esophageal spasm.In conclusion, outcomes after msa are diminished early on in patients with mild-to-moderate dge, but comparable by 1 year and durable at 2 years.Severe dge outcomes may be suboptimal.

Manufacturer Narrative

(b)(4).Date sent: 4/10/2024.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: 19079228
• MDR Text Key: 339877280
• Report Number: 3008766073-2024-00060
• 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: 04/10/2024

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: 03/28/2024
• Initial Date FDA Received: 04/10/2024
• 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): Required Intervention; Hospitalization