MAUDE Adverse Event Report: TORAX MEDICAL, INC. 1.5T LINX, 17 BEADS; ANTI-REFLUX IMPLANT

Model Number LXMC17

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); Hemorrhage/Bleeding (1888); Nausea (1970); Vomiting (2144)

Event Date 11/18/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 12/14/2020.(b)(4).As the device was not returned, an analysis investigation could not be performed.A conclusion could not be reached as to what may have caused or contributed to the event.The lot number was not provided; therefore, a manufacturing record evaluation could not be performed.Addtiional information: the surgeon noted that his patient has erosion of the esophagus due to the linx device.The device will be explanted.A date for that explanation has not been scheduled.Additional information was requested, and the following was obtained: what is the product code for this complaint? lxmc17.What is the lot number? not sure will work on obtaining it.If the device has been removed, what was the date of the explant? not removed yet.If the device is going to be removed, what is the date of the future explant? no date yet.Has the patient had any dilations, egd, or other procedures between the linx implant and the discovery of the erosion? please describe and include the dates of the procedures.The patient had an egd on (b)(6) and that¿s how they discovered the erosion.Are pictures or videos available? no.How many beads eroded? unclear.Where were the eroded beads positioned? no answer.Which best describes the device removal approach? the plan is to remove it endoscopically.Since the patient is doing ok and symptoms are under control, they are trying to wait a couple more weeks for the full capsulation to take place.Endoscopically removed the eroded beads initially & laparoscopically removed the device at a later date endoscopically removed the eroded beads & laparoscopically removed the device the same day endoscopically removed the entire device.Laparoscopically removed the entire device.Was the patient stented? no answer.What is the current condition of the patient? the patient is doing ok and symptoms are under control.Additional information was requested, and the following was obtained: what is the lot number? where were the eroded beads positioned? 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 that five weeks post-op to a linx implant for gerd and a hiatal hernia the patient woke up vomiting blood.The patient presented to his local hospital and an endoscopy revealed two of the beads had eroded into his esophagus.No clinical decisions have yet been reached by his physician on the next steps.

Manufacturer Narrative

(b)(4).Date sent: 1/6/2021.The dhr for lot 26522 was reviewed.No ncs, defects, or reworks related to the product complaint were found.Additional information was requested, and the following was obtained: what is the lot number? 26522.Where were the eroded beads positioned? inside the lumen of the esophagus.

Manufacturer Narrative

(b)(4).Date sent: 1/19/2021, maude report number: mw5098256, h6: pocket erosion (e200601).

• Brand Name: 1.5T LINX, 17 BEADS
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 11002067
• MDR Text Key: 221237960
• Report Number: 3008766073-2020-00196
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005370
• UDI-Public: 00855106005370
• Combination Product (y/n): N
• PMA/PMN Number: P100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 11/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/15/2024
• Device Model Number: LXMC17
• Device Catalogue Number: LXMC17
• Device Lot Number: 26522
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention