MAUDE Adverse Event Report: TORAX MEDICAL, INC. 1.5T LINX, 13B; ANTI-REFLUX IMPLANT

Model Number LXMC13

Device Problems Migration or Expulsion of Device (1395); Device Appears to Trigger Rejection (1524); Use of Device Problem (1670)

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

Event Date 11/01/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Unknown, assumed 1st day of the month that complaint was reported.As the device was not returned, an analysis investigation could not be performed.A conclusion could not be reached as to what may have caused or contributed to the event.The lot number was not provided; therefore, a manufacturing record evaluation could not be performed.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 is the lot number for the linx device? what was the date of the imaging which showed the discontinuous linx? if available, please share a copy of this imaging.When the patient underwent the mri what was the strength of the mri? did the patient have any other surgeries in the area? was any additional imaging performed since the 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 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 information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that the patient was implanted with the linx device on 3.8.2017.The patient did extremely well, her gerd was controlled.Approximately last november 2019 the patient went in for a torn rotator cuff and went in for an mri.The surgeon noted he just saw the patient last friday 11.13.2020.Immediately after the mri was turned on she felt severe pain in the epigastrium.As soon as the mri was turned off the pain went away.Since november of last year, she has experienced severe gerd symptoms like the linx device was not working.The patient had a barium swallow test and it was found the linx device was broken and was no longer circular and is just sitting there.The patient wants to have another linx implanted but the surgeon assumes that the disruption of the magnet beads occurred at the time of the mri.The surgeon knows that the beads were intact prior to that time and she was having no gerd symptoms.The patient is scheduled to have another mri and the surgeon does not want to remove the device and implant another linx if it is going to be disrupted again.

Manufacturer Narrative

(b)(4).Date sent: 4/28/2021.Photo was provided for review by ethicon medical safety officer.Following are their observations: i reviewed 5 xray images associated with this complaint.Three images were from 3/20/2017 and showed an intact linx device at the cardia.There were 2 images from the 11/4/2020 which showed a discontinuous linx device.There was a c shape with absence of the annular shape compared to the images obtained in 2017.These latest images are consistent with a disrupted and discontinuous linx device".Based on the reported lot number, the device is part of 2018 linx recall product bounding.However a hands on analysis of the affected device in needed to establish the mechanism/cause of failure.To date, no device has been returned.The dhr for lot 10253 was reviewed.No ncs, defects, or reworks related to the product complaint were found.Lot 10230 was an affected lot of the 2018 linx recall.

Manufacturer Narrative

(b)(4).Date sent: 04/26/2021.Additional information received: model: lxmc13, lot: 10253, serial: (b)(6).Unfortunately, the surgeon has not responded to the questions despite multiple attempts.Photo(s) received and are pending review.When the review is completed, a supplemental medwatch will be sent with a summary of the photographic evaluation.

Manufacturer Narrative

(b)(4).Date sent 1/21/2022.

Manufacturer Narrative

(b)(4); date sent: 1/18/2023.

Manufacturer Narrative

(b)(4).Date sent: 7/7/2023.Investigation summary: a 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 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 device was scanned using computer tomography (ct), optical microscopy, and scanning electron microscopy.The washer through-hole at the separation was measured and was greater than the specification.The washer through-hole was concentric with small amount of material displacement at the outer edge of the through hole.The overall appearance of the surface of the washer through hole exhibits 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 was concentric with the respect to the wire.

• Brand Name: 1.5T LINX, 13B
• 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: 10962726
• MDR Text Key: 220113313
• Report Number: 3008766073-2020-00187
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005332
• UDI-Public: 00855106005332
• Combination Product (y/n): N
• PMA/PMN Number: P100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/07/2023

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: 02/17/2020
• Device Model Number: LXMC13
• Device Catalogue Number: LXMC13
• Device Lot Number: 10253
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/17/2020
• Initial Date FDA Received: 12/07/2020
• Supplement Dates Manufacturer Received: 04/01/2021; 04/26/2021; 01/07/2022; 01/02/2023; 07/07/2023
• Supplement Dates FDA Received: 04/26/2021; 04/28/2021; 01/21/2022; 01/18/2023; 07/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: Z-2038-2018
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female