MAUDE Adverse Event Report: TORAX MEDICAL, INC. 1.5T LINX, 15B; ANTI-REFLUX IMPLANT

Model Number LXMC15

Device Problems Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Pyrosis/Heartburn (1883); Pneumonia (2011)

Event Date 01/01/2022

Event Type  Injury  

Event Description

It was reported that there was a removal of lxmc15 due to discontinuous device.

Manufacturer Narrative

(b)(4).Date of event: only event year known: 2022.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 was the date of implant? what was the date of the explant? what was the date of the imaging which showed the discontinuous linx? if available, please share a copy of this imaging.What is the device lot number? 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.Additional information received: dr.(b)(6) explanted a discontinuous linx device this week.He said he implanted a couple years ago.Upon explant, he performed a hiatal hernia repair and also performed a toupe.Patient is doing fine.At one point in the journey, he did do a dilation, but did not overexpand the device and x-rays post dilations showed intact.She was admitted back to the hospital for pneumonia and complaints of recurrent gerd.They x-rayed again and saw the discontinuous device.Photo analysis: ¿photo shows a discontinuous device, which is a known issue and described in the risk documents.¿ the engineering review of the explanted device found that the device is discontinuous, but it is not clear on the image whether there is a cut wire or a visible weld ball.A hands on analysis of the affected device is needed to establish the mechanism/cause of discontinuity.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: 3/31/2022.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 date of implant? what was the date of the explant? what was the date of the imaging which showed the discontinuous linx? if available, please share a copy of this imaging.What is the device lot number? 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.

Manufacturer Narrative

(b)(4).Date sent; 5/10/2022.Photo analysis: image of the explanted device was received and reviewed by the medical safety officer: "looks like a discontinuous device".A hands-on analysis of the device is necessary to assess the cause/mechanism of failure.A manufacturing record evaluation was performed for the finished device batch number 22649, and no non-conformances were identified.Investigation analysis: a 15-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 greater than the specification.The through-hole was nonconcentric with small amount of material displacement on the outer rim.The overall appearance of the surface of the washer through hole didn¿t exhibit gross loss of shape.The top view of the exposed weld ball diameter was measured and was within specification.The interference between the washer through-hole and the exposed weld ball diameters was 0.000,3".It is presumed that geometric combination of the through hole and weld ball led to the discontinuity of the device.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.Additional information was requested, and the following was obtained: what was the date of implant? what was the date of the explant? what was the date of the imaging which showed the discontinuous linx? if available, please share a copy of this imaging.What is the device lot number? 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.Answer - lot number 22649.Case completed without complications.Female dob (b)(6) 1966.Date of implant: (b)(6) 2019.Dilation on (b)(6) 2020.Dilated to 15mm.Date of explant: (b)(6), 2022.X rays received.

• Brand Name: 1.5T LINX, 15B
• 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: 13385305
• MDR Text Key: 284636977
• Report Number: 3008766073-2022-00026
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005356
• UDI-Public: 00855106005356
• 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
• Report Date: 05/10/2022

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: 08/10/2022
• Device Model Number: LXMC15
• Device Catalogue Number: LXMC15
• Device Lot Number: 22649
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/13/2022
• Initial Date FDA Received: 01/28/2022
• Supplement Dates Manufacturer Received: 03/15/2022; 04/27/2022
• Supplement Dates FDA Received: 03/31/2022; 05/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/10/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 55 YR
• Patient Sex: Female