MAUDE Adverse Event Report: TORAX MEDICAL, INC. 1.5T LINX, 15B; ANTI-REFLUX IMPLANT

Model Number LXMC15

Device Problem Patient Device Interaction Problem (4001)

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

Event Date 08/12/2020

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.No lot or batch number was provided therefore a device history could not be done.Additional information was requested, and the following was obtained: prior to linx placement, did the patient have an egd, ph, and manometry studies done? if yes, could you please share the results? on what date did the implant take place? on what date did the explant take place? what is the lot number of the linx device? when using the linx sizing device what technique was used to determine the size? did the patient have an autoimmune disease? is the patient currently taking steroids / immunization drugs? did the patient have any pre-existing dysphagia or other conditions (other than gerd)? how severe was the dysphagia/odynophagia before intervention? were there any intra-operative complications during implant? was there any hiatal or crural repair done at the same time as the implant? were there any other contributing factors that led to the removal of the device other than the reported dysphagia? besides, dysphagia, what was the reason for removal of the linx device? was the device found in the correct position/geometry at the time of removal? response= no additional information.

Event Description

It was reported that during a linx ex-plant, the linx was removed due to patient dysphagia.

Manufacturer Narrative

(b)(4).Date sent: 10/12/2020.Additional information received: device was removed for dysphagia.There was no mention in xray that a discontinuous linx was noticed.Device was implanted on (b)(6) 2017.Again, all we were able to find out from the surgeon.The implant was done either at navicent or coliseum.

Manufacturer Narrative

(b)(4).Date sent: 10/27/2020.The visual analysis found that the returned device had a visible well ball pulled out male bead.A slight rim was noted on the outer edge of the through-hole.No conclusions could be made whether the cause of the rim is supplier-related (machining process) or user-related.However, since this outer rim is only present on the outer surface of the male bead case and doesn¿t extend to the smallest diameter of the through-hole, it is not thought to have contributed to the weld ball pull through.The exposed weld ball diameter was found to meet specifications.The interference between the male bead case through-hole and the exposed weld ball diameters was 0.0001".The shape of the washer through hole connected to the wire with a visible weld ball was unusual, specifically the chambers appeared to be enlarged.It is unknown whether the cause is related to machining process by supplier and/or forces applied during use or explant procedure.However, this finding did not contribute to the user's experience since the wire was still connected to the washer and was able to retract into the bead per device design.The ct analysis of the inner structure of the beads at the disconnected junction did not find any evidence of part deformation that could have contributed to the failure.It is presumed that a certain geometric combination of the weld ball and the oversized male bead case through-hole resulted in the device separation in vivo.The link length and tensile force were found to meet the applicable specifications.The remaining device characteristics, excepting the visible weld ball, show no anomalies for a device that has been reasonably changed as part of the explant procedure.The lot was not provided; therefore, the manufacturing records could not be reviewed.This device is assumed to be outside of 2018 linx recall.

• Brand Name: 1.5T LINX, 15B
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 10559678
• MDR Text Key: 207705658
• Report Number: 3008766073-2020-00142
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005356
• UDI-Public: 00855106005356
• 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: 08/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: LXMC15
• Device Catalogue Number: LXMC15
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/30/2020
• Date Manufacturer Received: 10/21/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention