MAUDE Adverse Event Report: TORAX MEDICAL, INC. LINX 1.5 16 BEAD US; ANTI-REFLUX IMPLANT

Catalog Number LXMC16

Device Problem Material Erosion (1214)

Patient Problems Erosion (1750); Not Applicable (3189); No Code Available (3191)

Event Date 12/10/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional information was requested, and the following was obtained: i do not have much information on the patient.I was told by another physician that the linx was implanted at the same time as revision of gastric bypass.I have answered as many question as possible below.What were the first clinical symptoms that provided evidence of an erosion and when did they first occur? na.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.There has been egd¿s- i do not know how many or dates of the procedures.Are pictures or videos available? no.How many beads eroded? looked to be 2.Where were the eroded beads positioned? patients right side of the esophagus.Which best describes the device removal approach? laparoscopically.Endoscopically removed the eroded beads initially & laparoscopically removed the device at a later date- no.Endoscopically removed the eroded beads & laparoscopically removed the device the same day- no.Endoscopically removed the entire device- no.Laparoscopically removed the entire device- yes.Was the patient stented? not at the this time.What is the current condition of the patient? as of yesterday- the patient was still in the hospital.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.What were the first clinical symptoms that provided evidence of an erosion and when did they first occur? 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.How many beads eroded? what is the current condition of the patient?.

Event Description

It was reported post implant of linx device, the device was eroded into the esophagus.Unknown how the issue was diagnosed.A whole host was used; xray and endoscope.Explant; patient will be in the hospital for four or five days following surgery and possibly stented depending on how it heals.Any next steps required? no.

Manufacturer Narrative

(b)(4).Date sent: 02/20/2019.Device analysis: 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 device lot number is unknown; therefore, the device history record could not be reviewed.

• Brand Name: LINX 1.5 16 BEAD US
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 8220425
• MDR Text Key: 132201505
• Report Number: 3008766073-2019-00230
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005363
• UDI-Public: 00855106005363
• 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: 12/10/2018

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 Catalogue Number: LXMC16
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/26/2018
• Initial Date Manufacturer Received: 12/10/2018
• Initial Date FDA Received: 01/04/2019
• Supplement Dates Manufacturer Received: 02/14/2019
• Supplement Dates FDA Received: 02/20/2019
• Patient Sequence Number: 1