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

Catalog Number UNK LINX MAGNETIC IMPLANT

Device Problem Material Erosion (1214)

Patient Problems Adhesion(s) (1695); Erosion (1750); Pain (1994); No Code Available (3191)

Event Date 12/01/2013

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 10/01/2019.Date of event: unknown, assumed the 1st day of month that complaint was reported.The lot was not provided; therefore, the manufacturing records could not be reviewed.

Event Description

It was reported via journal article: title: two-stage explantation of a magnetic lower esophageal sphincter augmentation device due to esophageal erosion author/s: abhishek d.Parmar, md, ms, robert a.Tessler, md, howard y.Chang, md and jonathan d.Svahn, md, facs.Citation: journal of laparoendoscopic & advanced surgical techniques volume 27, number 8, 2017 / doi: 10.1089/lap.2017.0153.The purpose of this case report was to present a staged approach to the management of a case of device erosion at 4 years after linx placement.This is a case of a (b)(6)-year-old female who initially presented with symptoms of longstanding hoarseness, throat pain, and odynophonia.She also noted periodic atypical chest pain.In the spring of 2011, she subsequently underwent placement of a 12-bead linx.Her hospital course was complicated by persistent dysphagia, requiring prolonged parenteral nutrition for several weeks.She did note subjective improvement in her symptoms with normalization of her voice and resolution of throat pain.In (b)(6) 2013, she began to have recurrent odynophonia and complaints of pain with swallowing in (b)(6) 2013.After conservative management, she underwent esophagogastroduodenoscopy (egd), two beads were identified in the distal esophageal lumen, consistent with partial device erosion.The two beads were identified in the left lateral position at the lower esophageal sphincter.The communicating wires on the outer ends of the beads were transected using a polyloop cutter.Magnets were placed into a roth net and extracted.Subsequent evaluation of the erosion site did not reveal any large full-thickness injury.The patient was admitted for observation and underwent an esophagram post procedure to exclude occult perforation.After a 3-month period of recovery, the patient underwent laparoscopy to remove the remainder of the device.There were few dense adhesions along a capsule surrounding the device, which were transected using endoscopic scissor dissection and bovie electrocautery.The 10 remaining beads were grasped and easily extracted out of its fibrous capsule en bloc.Next, the fibrous capsule surrounding the device was reapproximated using interrupted vicryl sutures.The patient underwent a final esophagram, which once again confirmed no leak.The patient denied any symptoms of odynophagia nor any complaints of subjective reflux.She denied any difficulty swallowing or ongoing symptoms of reflux.Transmural erosion of the linx device into the esophageal lumen is a rare occurrence, with only five such complications reported in the published literature.We present the first account of linx explantation for esophageal erosion in the united states.We demonstrated that a staged laparoendoscopic approach to linx removal in these cases is feasible with minimal morbidity.

• 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: milt garrett ; 4188 lexington avenue north; shoreview, MN
• MDR Report Key: 9139837
• MDR Text Key: 163599672
• Report Number: 3008766073-2019-00492
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2019
• 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?: Yes
• Date Manufacturer Received: 09/17/2019
• 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