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

Catalog Number LXMC13

Device Problems Break (1069); Detachment of Device or Device Component (2907); Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 01/20/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The lot was not provided; therefore, the 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.Was it confirmed that the linx device is discontinuous? if yes, what was the date of the imaging which showed the discontinuous linx? if available, please share a copy of this imaging.Please send to (b)(4).When was the device implanted? what is the lot number of the device? was the device initially effective in controlling the reflux? 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 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, linx implanted and the circular band has broken and not connected anymore.It has also become encapsulated.In his estimation (per the patient) "it may have been to tight".He has had some issues with reflux.He has had problems with swallowing, but the choking has been more of an issue.He has had issues since it was implanted.His doctor has done some testing on the reflux issue and was determined that it was normal.There is no scheduled date to have the device removed, doctor and patient are holding off for a year to see how it works out.The device is a thirteen-beaded device.The surgeon who implanted the device is dr.(b)(6).

Manufacturer Narrative

(b)(4).Per photographic evaluation: an x-ray image of the device in vivo was received.The device seems to be annular in posterior-anterior x-ray view.However, in the lateral x-ray view, the device doesn't seem to have the expected annular shape.The "c" shape of the device in the lateral x-ray view seems consistent with a discontinuous device.The mechanism/cause of failure cannot be determined from the x-ray provided.

Manufacturer Narrative

(b)(4).Additional information received: clarification received: implant date was (b)(6) 2017 imaging results received.(b)(4).

Manufacturer Narrative

(b)(4).The dhr for lot 12939 was reviewed.No ncs, reworks, or defects were found.Lot 12393 is a lot affected by the 2018 linx recall.Additional information requested and received: patient id: (b)(6).Dob (b)(6) 1982.When was the device implanted? (b)(6) 2017.What is the lot number of the device? lot 12939.Was the device initially effective in controlling the reflux? yes.Was any additional imaging performed since device implant? (b)(6) 2018 chest xray and esophagram.Does the device appear to be in a continuous annular state in these images? yes.We are interested in establishing a window when the device may have become discontinuous.Please share any additional images.(b)(6) 2018 chest x-ray and chest ct shows linx in discontinuity.What is the management plan? is device removal scheduled? is a replacement linx or fundoplication planned? patient has control of reflux with taking medications as needed.Recent upper endoscopy with ph testing shows continued ph normalization.Patient does not want device removed at this time.No further surgical intervention planned at this time.Recommending continued annual surveillance with egd/ph testing.When and if the explanation takes place can we ask that the procedure gets video recorded and the video shared? yes.When and if the linx device is removed, may we ask that the device be returned for analysis? yes.Weight: 178 lb.Date of implant: (b)(6) 2017.Implanting physician: dr.(b)(6).Device size: 13-bead clasp.Pre-implant information: barium swallow, egd/ph may have been completed at gi's office prior to referral for surgery (don't currently see on record on hoag chart).There has been follow up egd/bravo done post surgery (b)(6) 2017 and (b)(6) 2017.Did the patient have any pre-existing dysphagia or other conditions (other than gerd)? no.Were there any intra-operative complications during implant? no.Was there any hiatal or crural repair done at the same time as the implant? yes.Was mesh used at time of implant? no.What was the reason for removal of the linx device? linx will not be removed at this time.If dysphagia, how severe was the dysphagia/odynophagia before intervention? moderate, discomfort intense enough to cause interference with usual activities (able to eat soft, but not solid food).Was the device found in the correct position/geometry at the time of removal? no.The device is disconnected but per the patient and surgeon they will leave it in place since patient is doing well.

• Brand Name: 1.5T LINX, 13B
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 8424573
• MDR Text Key: 138919423
• Report Number: 3008766073-2019-00292
• Device Sequence Number: 1
• Product Code: LEI
• Combination Product (y/n): N
• PMA/PMN Number: P100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/22/2020
• Device Catalogue Number: LXMC13
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/19/2019
• Patient Sequence Number: 1