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

Model Number LXMC14

Device Problems Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Chest Pain (1776); Pyrosis/Heartburn (1883)

Event Date 01/25/2022

Event Type  Injury  

Event Description

It was reported that the patient's gerd symptoms reappeared so she underwent an egd with fluoroscopy for possible dilation.It was noted the device was disrupted.An mri had been performed at one point and noted chest pain.It is unknown if the device is explanted.

Manufacturer Narrative

(b)(4).Exact month of event is unknown.Assumed january.Lot number was received and dhr is pending review.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: was the patient suffering from gerd¿s and/or dysphagia before she underwent the egd for possible dilation? did she go under a dilation? what was the date of implant? when did the reoccurring gerd¿s symptoms return? what was the date of the imaging which showed the discontinuous linx? if available, please share a copy of this imaging.What is the product code? was the device initially effective in controlling reflux? were any events associated with the onset of symptoms (vomiting, retching, trauma, surgery)? when was the mri taken and at what strength was the mri? did the patient have any other surgeries in the area? was any additional imaging performed since device implant? does the device appear to be in a continuous annular state in these images? we are interested in establishing a window when the device may have become discontinuous.Please share any additional images.What is the management plan? is device removal scheduled? is a replacement linx or fundoplication planned? when is the explant supposed to take place? when and if the explanation takes place can we ask that the procedure gets video recorded and the video shared? when and if the linx device is removed, may we ask that the device be returned for analysis?.

Manufacturer Narrative

(b)(4).Date sent: 4/13/2022.Investigation summary : an analysis of the product could not be performed since a physical sample was not received for evaluation.A manufacturing record evaluation was performed for the finished device batch number 22561 , and no non-conformances were identified.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.However, if the product is received at a later date, the investigation will be updated as applicable.

Manufacturer Narrative

(b)(4).Date sent: 6/16/2022.

Manufacturer Narrative

(b)(4), date sent; 8/9/2022.D6b: exact explant date is unknown.Since the alert date of the file is (b)(6) 2022 assumption is made the explant was performed around (b)(6) 2022.Explant date will be captured as (b)(6) 2022.Investigation summary the visual assessment of the device noted a washer disconnected from a female bead case.One weld track was partially burnt, presumably, with a surgical tool on both the bead case and the washer.The second weld track is visible on both the washer and bead case.The washer was grossly bent with the weld tracks closest to the bead case and the sides (90 deg away from weld tracks) bent outwards.These findings suggest that the washer was pulled out of the female bead case due to external forces applied during an explant procedure.The device also had a visible weld ball disconnected from a washer.Visualization of the internal features of the beads adjacent to the weld ball pull through (failed link) was made using computer tomography (ct).These ct scans produced a digital 3d volume reconstruction that could be analyzed non-destructively.The affected washer through hole diameter was measured with computed tomography and was greater than the specifications.The trough hole was non-concentric and had a small amount of material displacement on the outer edge.The overall appearance of the surface of the washer didn't exhibit gross loss of shape.The top view of the diameter of the exposed weld ball was measured.This diameter is within the specification.The weld ball appears to be spherical and slightly non-concentric with respect to the wire.It is presumed that a certain geometric combination of the weld ball and the washer hole resulted in the device separation.Overall review of the device function and dimensions, excepting for disconnected washer and a weld ball pull through, 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.

• Brand Name: 1.5T LINX, 14B
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• Manufacturer Contact: kara ditty-bovard ; 4188 lexington avenue north; shoreview 55126 ; 6107428552
• MDR Report Key: 13710754
• MDR Text Key: 286861799
• Report Number: 3008766073-2022-00051
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005349
• UDI-Public: 00855106005349
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/16/2022

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: 08/09/2022
• Device Model Number: LXMC14
• Device Catalogue Number: LXMC14
• Device Lot Number: 22561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/24/2022
• Initial Date FDA Received: 03/09/2022
• Supplement Dates Manufacturer Received: 04/13/2022; 06/07/2022; 08/01/2022
• Supplement Dates FDA Received: 04/13/2022; 06/16/2022; 08/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention