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); Patient Device Interaction Problem (4001)

Patient Problems Erosion (1750); Dysphagia/ Odynophagia (1815); No Code Available (3191)

Event Date 06/12/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.The lxmc17 was found to have eroded into the esophagus.The lxmc17 was removed entirely endoscopically.At the time of removal of the lxmc17, a green suture with an unknown metal component was also found endoluminally.That was also removed.Additional information requested: what is the lot # of the device? what were the first clinical symptoms that provided evidence of an erosion and when did they first occur? patient has complained of dysphagia since implant of the lxmc17 on (b)(6) 2020.Has the patient had any dilations, egd, or other procedure between the linx implant and discovery of the erosion? please describe and include the dates of the procedures.Egd monday (b)(6).How many beads eroded? not sure ¿ we were able to move device entirely endoscopically.Where were the eroded beads positioned? not sure.Was the patient stented? no.What is the current condition of the patient? unknown.Prior to linx placement, did the patient have an egd, ph, and manometry studies done? if yes, could you please share the results? when using the linx sizing device what technique was used to determine the size? as described in the ifu with a pop off +3.Did the patient have an autoimmune disease? no.Is the patient currently taking steroids / immunization drugs? unknown.Did the patient have any pre-existing dysphagia or other conditions (other than gerd)? unknown.How severe was the dysphagia/odynophagia before intervention? were there any intra-operative complications during implant? no.Was there any hiatal or crural repair done at the same time as the implant? yes.Were there any other contributing factors that led to the removal of the device other than the reported dysphagia? erosion.Was the device found in the correct position/geometry at the time of removal? eroded.If information is obtained that was not available for the initial report, a follow-up report will be field as appropriate.

Event Description

It was reported that the lxmc17 was explanted due to dysphagia and pain.The entire device was removed endoscopically because the device had eroded into the esophagus.While removing the device a green suture was found and also removed.The device was implanted on (b)(6) 2020 and removed (b)(6) 2020.The surgeon who removed the device is the surgeon who implanted the device.

Manufacturer Narrative

(b)(4).Date sent: 07/20/2020.Additional information was requested, and received: what is the lot # of the device? i don¿t not have this info.How severe was the dysphagia/odynophagia before intervention? severe ethicon medical review: i reviewed a photograph which was an endoscopic view of what appears to be the gastroesophageal junction.At the 6 and 7 o¿clock position there is evidence of erosion of a linx device into the esophageal lumen.One bead is clearly visible with the impression of 2 other beads.

Manufacturer Narrative

(b)(4).Date sent: 8/4/2020.Device analysis: the visual analysis was consistent with an explanted device - the device was returned in two segments with a cut wire.Overall review of the device function and dimensions show no anomalies from a device that has been reasonably changed as part of the explant procedure.Visual analysis was consistent with an explanted device, and link length and tensile force were found to meet the applicable specifications during device analysis.No conclusions relevant to the patient experience were found during the device analysis.The lot was not provided; therefore, the manufacturing records could not be reviewed.

• 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: 10195203
• MDR Text Key: 201270404
• Report Number: 3008766073-2020-00092
• 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: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 06/12/2020

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 Model Number: LXMC17
• Device Catalogue Number: LXMC17
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2020
• Initial Date Manufacturer Received: 06/12/2020
• Initial Date FDA Received: 06/25/2020
• Supplement Dates Manufacturer Received: 06/26/2020; 07/06/2020
• Supplement Dates FDA Received: 07/20/2020; 08/04/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention