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

Catalog Number LXMC13

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); Insufficient Information (4580)

Event Date 01/01/2024

Event Type  Injury  

Event Description

It was reported that a linx device that had broken apart on the back side was explanted.The device was placed on (b)(6) 2015.The patient did have several mri¿s (i believe all 1.5 tesla or lower) and some dilations from gi.No additional linx placed per patient request.

Manufacturer Narrative

(b)(4).Date sent: 2/16/2024 b3: only event year known: 2024.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.No lot number was provided therefore a device history could not be done.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 symptoms lead to the discovery of the discontinuous device? when did they begin? what was the date of the imaging which showed the discontinuous linx? if available, please share a copy of this imaging.Please send to: productcompliant1@its.Jnj.Com.What is the device lot number? when was the explanted date? 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.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.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: 4/4/2024 investigation summary a linx device with a visible weld ball that disconnected from a male bead case 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, tooling marks were noted in some beads.The device was scanned using computer tomography (ct), optical microscopy, and scanning electron microscopy.The male bead case at the separation was measured and was greater than the specification.The male bead case was concentric with small amount of material displacement at the outer edge of the through hole.The overall appearance of the surface of the male bead case through hole 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 was concentric with the respect to the wire.A manufacturing record evaluation was performed for the finished device 8162 number, and no non-conformances related to the malfunction were identified.

Manufacturer Narrative

(b)(4); date sent: 2/29/2024.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.Additional information was requested, and the following was obtained: what symptoms lead to the discovery of the discontinuous device? epigastric pain, dysphagia and acid reflux.When did they begin? (b)(6) 2023.What was the date of the imaging which showed the discontinuous linx? if available, please share a copy of this imaging.Please send to: productcompliant1@its.Jnj.Com ugi nov 2023 showed an open linx device what is the device lot number? trying to find in epic, will have to update you with it once we can find it.Device placed on 12/10/2015 when was the explanted date? 2/1/2024 was the device initially effective in controlling reflux? yes, she was on and off ppi¿s for some intermittent symptoms, but overall had + reflux control.Were any events associated with the onset of symptoms (vomiting, retching, trauma, surgery)? she had intermittent heartburn and dysphagia.From one gi note 8/2022 there is reported abdominal pain after an mri of the knees.No dysphagia at this time.She was off ppi¿s at this time without reflux symptoms.Another gi nurse note from 8/2023: increase in her gerd symptoms and feeling "racey" where her linx is located.She states that her food gets stuck and builds about one a week where she needs to "lean over the toilet and it just falls back out of my mouth".She feels she is needing a dilation.She also says that she had an mri for her knee and she had to make them stop due to her feeling the mri pulling on her linx and is concerned that something may have happened to it.Did the patient undergo an mri since device implant? if so, when was the mri and what strength? mri¿s: 8/2022 knees ¿ 1.5 t 2/2020 c-spine ¿ 1.5 t 8/2018: head ¿ 1.5 t 1/2018 c-spine ¿ 1.5 t did the patient have any other surgeries in the area? no surgeries, but egd¿s as below: egd¿s with dilation: 8/2016 for intermittent dysphagia: dilatation was performed, using a balloon.20 mm dilators were passed.2/2018 for dysphagia: a tts dilator was passed through the scope.Dilation with an 18-19-20 mm balloon dilator was performed to 20 mm.12/2020 for dysphagia: ge junction was dilated with an 18 mm tts balloon dilator.Inflated balloon could move freely within the ge junction.9/2023 for dysphagia and heartburn: no dilation reported 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.This is from a fluoro report on 1/23/24: the magnetic ring appears unchanged from abdominal x-ray 11/9/2023.It is favored that the magnetic ring now has a persistent gap that was not present on chest x-ray of november 2020 and ct abdomen/pelvis of september 2016.The gap was partly present on lumbar spine x-ray 4/13/2021.

Manufacturer Narrative

(b)(4).Additional information received; i was not sure of the size of linx device until boxing up in the shipper kit.It appears to be a size 13 (i believe), not a 16 as listed originally.

• 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: kate karberg ; 4545 creek rd.; cincinnati, OH 45242 ; 3035526892
• MDR Report Key: 18725210
• MDR Text Key: 335720880
• Report Number: 3008766073-2024-00033
• Device Sequence Number: 1
• Product Code: LEI
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: LXMC13
• Device Lot Number: 8162
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention