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); Patient Device Interaction Problem (4001)

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

Event Date 10/17/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).No lot number was provided therefore a device history could not be done.Additional information was requested, and the following was obtained: what is the exact date of the implant? unknown.What is the lot number? unknown.Besides dysphagia were there any other clinical symptoms that provided evidence of erosion and when did they first occur? unknown.Are pictures or videos available of the dilation? unknown.How many beads eroded? unknown.Which best describes the device removal approach? the device was removed laparoscopically, dr.Said he couldn¿t do it 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? unknown.What is the current condition of the patient? the patient was transferred to dr.Leeds for a follow-up surgery.Unknown after that.Was there any intervention with the erosion of the mesh of feb 2020? some mesh was removed endoscopically.But at the time he said he did not see any linx beads in the esophagus so nothing was done with the linx device at that time.

Event Description

It was reported that there was a linx implant erosion in the esophagus.17 bead- device.Device was implanted 1 year ago.Patient had a nissen fundoplication undone and replaced with a linx.Also had a recurring hiatal hernia repaired.The physician did an egd (patient was having dysphagia) in (b)(6) 2020, and noticed the rare event of an absorbable mesh had eroded into the esophagus, but did not notice any linx beads at that time.On (b)(6) 2020, he did scope the patient again, and found a linx bead had eroded into the esophagus.Linx device was removed on (b)(6) 2020.Procedure: lap reflux.

Manufacturer Narrative

(b)(4) date sent: 11/23/2020 f10, h6: erosion device analysis: a suture on a wire adjacent to one of the cut wire was observed during the visual assessment.It is known that sometimes, during the explant procedure, a suture is placed on the device to aid in the extraction of the device.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.Overall, no analysis conclusions relevant to the patient experience were found.The lot/batch 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: 10829150
• MDR Text Key: 216391414
• Report Number: 3008766073-2020-00171
• 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
• Report Date: 10/16/2020

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?: Yes
• Device Operator: Health Professional
• Device Model Number: LXMC17
• Device Catalogue Number: LXMC17
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/06/2020
• Initial Date Manufacturer Received: 10/16/2020
• Initial Date FDA Received: 11/12/2020
• Supplement Dates Manufacturer Received: 11/19/2020
• Supplement Dates FDA Received: 11/23/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Weight: 113