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

Model Number LXMC15

Device Problems Device Appears to Trigger Rejection (1524); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pyrosis/Heartburn (1883); Pain (1994)

Event Date 05/19/2021

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 13161 was reviewed.No ncs, defects, or reworks related to the product complaint were found.Lot 13161 was an affected lot of the 2018 linx recall.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? egd normal.Demeester score 206.Manometry done on outside but reportedly normal per previous surgeon¿s notes.What is the exact implant date? (b)(6) 2018.What is the lot number of the linx device? 13161.When using the linx sizing device what technique was used to determine the size? did not perform index operation.Did the patient have an autoimmune disease? no.Is the patient currently taking steroids / immunization drugs? no.Did the patient have any pre-existing dysphagia or other conditions (other than gerd)? none per previous notes.How severe was the dysphagia/odynophagia before intervention? none per notes.Were there any intra-operative complications during implant? none reported.Was there any hiatal or crural repair done at the same time as the implant? posterior cruraplasty with silk suture.Were there any other contributing factors that led to the removal of the device other than the reported dysphagia? failure of multiple previous attempts at endoscopic dilation.Besides the reported dysphagia, what was the reason for removal of the linx device? worsened gerd, epigastric pain on waking every day and before first meal.Was the device found in the correct position/geometry at the time of removal? no, there was a recurrent hiatal hernia and the linx was essentially positioned within the crura.Additional information was requested, and the following was obtained: please confirm: in the previous additional information you provided it was stated that the device was removed due to dysphagia and worsened gerd.However, in a question we asked you, ¿how severe was the dysphagia/odynophagia before intervention?¿, the answer you provided was ¿none reported¿.Was the device removed due to dysphagia? device was removed due to worsening gerd and pain as per surgeon¿s initial answer to questions.

Event Description

It was reported that the linx device was explanted on (b)(6) 2021.Due to dysphagia issues.The device was initially implanted four years ago.

Manufacturer Narrative

(b)(4).Date sent: 6/28/2021.H6: no device problem found (c19).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.During the visual analysis of the device, tooling marks were found on the clasp beads.Visual analysis was consistent with an explanted device, and link length and tensile force were found to meet the applicable specifications.No further investigation will be conducted on this complaint as the device is found to meet the specifications.Overall, no analysis conclusions relevant to the patient experience were found.

• 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: 11938412
• MDR Text Key: 255613686
• Report Number: 3008766073-2021-00106
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 05/18/2021

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: 12/13/2020
• Device Model Number: LXMC15
• Device Catalogue Number: LXMC15
• Device Lot Number: 13161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2021
• Initial Date Manufacturer Received: 05/18/2021
• Initial Date FDA Received: 06/04/2021
• Supplement Dates Manufacturer Received: 06/16/2021
• Supplement Dates FDA Received: 06/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Removal/Correction Number: Z-2038-2018
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR