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

Model Number LXMC14

Device Problems Device Appears to Trigger Rejection (1524); Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dysphagia/ Odynophagia (1815); Pyrosis/Heartburn (1883); Pain (1994); Hernia (2240)

Event Date 03/08/2022

Event Type  Injury  

Event Description

It was reported that the patient was experiencing relapse a of gerd and after testing and some imaging it was found that the device was discontinuous.Explant is not yet scheduled.Patient is scheduled to return in two weeks.

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.Lot number was received and dhr is pending review.When the review is completed, a supplemental medwatch will be sent with a summary of the evaluation.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: what was the exact date of implant? when did the symptoms of gerds begin? what was the date of the imaging which showed the discontinuous linx? if available, please share a copy of this imaging.Was the device initially effective in controlling reflux? were any events associated with the onset of symptoms (vomiting, retching, trauma, surgery)? did the patient undergo an mri since device implant? if so, when was the mri and what strength? 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 date set? 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? if yes for being return for analysis what is a good address to send the shipper kit to? please provide full name and address.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

(b)(4).Date sent: 4/14/2022.Additional information provided: it was reported that the patient became symptomatic with persistent cough, dysphagia, and pain approximately sixty days ago.An endoscopy confirmed a discontinuous linx device.Spoke with patient who indicated her linx device was removed yesterday.Once she¿s more fully recovered, she will follow up with me and has my contact information.She believes the device is being returned to us.Patient returned my call today and is doing well and has returned to work but is taking it easy at work this week.Her surgeon is (b)(6), md and the device was explanted at (b)(6) medical center in (b)(6), ms on (b)(6) 2022.The surgeon advised her he would be returning the device for analysis.Linx photo images were received and are pending review.When the review is completed, a supplemental medwatch will be sent with a summary of the evaluation.

Manufacturer Narrative

(b)(4).Date sent: 5/10/2022.Photo analysis: the photo was reviewed by a medical safety officer.As per medical safety officer: "the photo demonstrates a discontinuous device".The mechanism/cause of failure cannot be determined from the provided image.Device analysis: a 14-bead linx device with a visible weld ball that disconnected from a washer was returned to the analysis site.The link length and tensile force measurements were found to meet the applicable specifications during device analysis.The device was scanned using computer tomography (ct), optical microscopy, and scanning electron microscopy.The washer through-hole at the separation was measured and was found to be greater than the specification.The washer through-hole was nonconcentric and had small amount of material displacement at the outer edge of the through-hole.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 off-axis with respect to the wire.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.A manufacturing record evaluation was performed for the finished device 13536 batch number, and no non-conformances were identified.Lot 13536 was an affected lot of the 2018 linx recall.

Manufacturer Narrative

(b)(4).Date sent:(b)(6) 2023 see op notes d6a.

• Brand Name: 1.5T LINX, 14B
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4545 creek road; cincinnati OH
• Manufacturer Contact: kara ditty-bovard ; 4188 lexington avenue north; shoreview 55126 ; 6107428552
• MDR Report Key: 13825399
• MDR Text Key: 292226051
• Report Number: 3008766073-2022-00063
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/06/2023

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: 01/10/2021
• Device Model Number: LXMC14
• Device Catalogue Number: LXMC14
• Device Lot Number: 13536
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/08/2022
• Initial Date FDA Received: 03/19/2022
• Supplement Dates Manufacturer Received: 03/29/2022; 04/20/2022; 10/26/2023
• Supplement Dates FDA Received: 04/14/2022; 05/10/2022; 11/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: Z-2038-2018
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female