MAUDE Adverse Event Report: TORAX MEDICAL, INC. LINX 1.5T 14 BEAD OUS; ANTI-REFLUX IMPLANT

Catalog Number LXM14

Device Problems Device Appears to Trigger Rejection (1524); Patient Device Interaction Problem (4001)

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

Event Date 10/28/2020

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.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Additional information was requested, and the following was received: prior to linx placement, did the patient have an egd, ph, and manometry studies done? if yes, could you please share the results? yes egd, ph, - issues with where the device was sitting from endoscopy point of view and acid levels were normal on what date did the implant take place? not sure.When using the linx sizing device what technique was used to determine the size? standard practice for sizing.Did the patient have an autoimmune disease? not to the knowledge of the surgeon is the patient currently taking steroids / immunization drugs? no.Did the patient have any pre-existing dysphagia or other conditions (other than gerd)? no.How severe was the dysphagia/odynophagia before intervention? the patient managed with the dysphagia for about 6 months but just wanted the device removing were there any intra-operative complications during implant? no.Was there any hiatal or crural repair done at the same time as the implant? yes.Were there any other contributing factors that led to the removal of the device other than the reported dysphagia? no.What was the reason for removal of the linx device? patient just wanted the device removing.Was the device found in the correct position/geometry at the time of removal? yes.If information is obtained that was not available for the initial report, a follow-up report will be field as appropriate.

Event Description

It was reported there was an explant of the linx device.Patient found certain types of fluid hard to swallow, no issues with food.Asked for the device to removed.

Manufacturer Narrative

(b)(4).Date sent: 12/14/2020.H6: investigation findings= c01.Additional information: the device was not examined in detail at the time because it formed a perfect circle with the magnets working properly so was put straight into a biohazardous bag.Did the surgeon notice anything wrong with the device prior to explant? no.Could they help us understand at what point the washer became loose? no idea, device was placed straight into a biohazardous bag.Device analysis: the explanted device was returned in one piece.The visual analysis found one washer that was detached from a bead adjacent to a clasp bead.As per additional, during the explant procedure the device was not examined in detail at the time because it formed a perfect circle with the magnets working properly.In addition, the customer did not notice anything out of ordinary.Hence, it is presumed that the washer was intact prior to explant, and was pulled out during the explant procedure due to the applied force (i.E.The loose washer didn¿t contribute to the patient¿s experience).The visual analysis excepting the unseated washer was consistent with an explanted 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.The link length and tensile force were found to meet the applicable specifications.Overall, no analysis conclusions relevant to the patient experience were found.The dhr for lot 22651 was reviewed.No ncs, defects, or reworks related to the product complaint were found.Mfg date: 08/14/2018.Exp date:08/14/2022.

• Brand Name: LINX 1.5T 14 BEAD OUS
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 10842960
• MDR Text Key: 216330362
• Report Number: 3008766073-2020-00177
• Device Sequence Number: 1
• Product Code: LEI
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 10/28/2020

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 Expiration Date: 08/14/2022
• Device Catalogue Number: LXM14
• Device Lot Number: 22651
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2020
• Initial Date Manufacturer Received: 10/28/2020
• Initial Date FDA Received: 11/16/2020
• Supplement Dates Manufacturer Received: 12/04/2020
• Supplement Dates FDA Received: 12/14/2020
• Patient Sequence Number: 1