MAUDE Adverse Event Report: TORAX MEDICAL, INC. LXC12; ANTI-REFLUX IMPLANT

Catalog Number LXC12

Device Problems Material Erosion (1214); Malposition of Device (2616)

Patient Problems Pocket Erosion (2013); No Code Available (3191)

Event Date 04/23/2019

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 dhr for lot 3878 was reviewed.No ncs, defects, or reworks were found.

Event Description

It was reported, linx removed due to erosion.The patient did not have an autoimmune disease.Medication taken, lansoprazole 2 weeks.The implant date is unknown.There were no intra-op complications.There was no hiatal hernia/crural done at the time of implant.The device was not found at the correct position/geometry at the time of removal (erosion).A new linx was not place after the initial linx was removed.Thee beads eroded.The patient stayed 2 days and then was discharged.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).Date sent: 07/17/2019.Additional information was requested, and the following was obtained: what was the date of implant? 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.Where were the eroded beads positioned? was the patient stented? response: there is no additional information for this complaint.

Manufacturer Narrative

(b)(4).Date sent:09/04/2019.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.

• Brand Name: LXC12
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 8617275
• MDR Text Key: 145294972
• Report Number: 3008766073-2019-00351
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005134
• UDI-Public: 00855106005134
• Combination Product (y/n): N
• PMA/PMN Number: P100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/02/2019

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 Expiration Date: 08/17/2016
• Device Catalogue Number: LXC12
• Device Lot Number: 3878
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/31/2019
• Initial Date Manufacturer Received: 05/02/2019
• Initial Date FDA Received: 05/16/2019
• Supplement Dates Manufacturer Received: 05/31/2019; 06/26/2019; 08/20/2019
• Supplement Dates FDA Received: 06/18/2019; 07/17/2019; 09/04/2019
• Patient Sequence Number: 1