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

Model Number LXMC14

Device Problems Migration or Expulsion of Device (1395); Patient Device Interaction Problem (4001)

Patient Problems Dysphagia/ Odynophagia (1815); Pyrosis/Heartburn (1883); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Only event year known: 2020.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.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? besides gerds 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.Was the device initially effective in controlling reflux? when did the recurrent reflux begin? 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 the explant takes place can you please let us know.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?.

Event Description

It was reported that the doctor took care of a patient that had linx device implanted in 2017 model lxmc14 lot# 13077.The patient began having increased reflux and was sent for imaging.The patient was having trouble swallowing u-shape configuration of device was noted and patient is to have device explanted after her covid-19 test is negative and she is out of isolation.

Manufacturer Narrative

(b)(4).Date sent: 10/5/2020.The dhr for lot 13077 was reviewed.No ncs, defects, or reworks related to the product complaint were found.

Manufacturer Narrative

(b)(4).Date sent: 11/19/2020.Additional information: user facility mw: # mw5097316.Linx device, implanted in 2017, has broken internally and she will have to have it replaced.The procedure is scheduled for (b)(6) 2020.Initials: (b)(6); date of implant (b)(6) 2017; the device was removed on (b)(6) 2020; symptoms started around (b)(6) 2019.Experienced regular acid reflux didn't understand what was wrong.Lot number of the device is #13077-lxmc14.Per photographic evaluation: upon visual inspection of the photos, the device doesn't seem to have the expected annular shape in the x-ray image.The "c" shape of the device seems consistent with a discontinuous device.Unfortunately the mechanism/cause of failure cannot be determined from the provided x-ray image.Device analysis: the visual analysis found that the returned device had an exposed well ball paired with the washer side of the adjacent bead.The affected washer through hole diameter was measured and found to be greater than the specification.The exposed weld ball diameter was found to meet specifications.The interference between the washer through-hole and the exposed weld ball diameters was 0.00002".It is presumed that a certain geometric combination of the weld ball and the washer through-hole resulted in the device separation in vivo.Link length and tensile force were found to meet the applicable specifications during device analysis.No anomalies for a device that has been reasonably changed as part of the explant procedure.This device is affected by the 2018 linx recall based on the reported lot number 13077.

Manufacturer Narrative

(b)(4).Date sent: 3/8/2021.Additional information received: received operative notes.

• Brand Name: 1.5T LINX, 14B
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 10442651
• MDR Text Key: 204206974
• Report Number: 3008766073-2020-00129
• 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: health professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/31/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/02/2020
• Device Model Number: LXMC14
• Device Catalogue Number: LXMC14
• Device Lot Number: 13077
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2020
• Initial Date Manufacturer Received: 07/31/2020
• Initial Date FDA Received: 08/24/2020
• Supplement Dates Manufacturer Received: 09/21/2020; 10/29/2020; 02/12/2021
• Supplement Dates FDA Received: 10/06/2020; 11/19/2020; 03/08/2021
• Removal/Correction Number: Z-2038-2018
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR