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 Fatigue (1849); Pain (1994); Vomiting (2144); Decreased Appetite (4569); Insufficient Information (4580)

Event Date 01/01/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Only event year known: 2022.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 productcomplaint1@its.Jnj.Com 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.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? 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.

Event Description

It was reported that a linx device has become discontinuous and will be explanted at an unknown time.It was verified with imaging.

Manufacturer Narrative

(b)(4); date sent: 11/18/2022.Photo analysis: the photo was reviewed by a medical safety officer.As per medical safety officer: the ct image demonstrates a discontinuous linx device located below the diaphragm.A hands-on analysis is necessary to determine the cause of failure.A manufacturing record evaluation was performed for the finished device batch number 19820, and no related nonconformances were identified.Additional information was requested, and the following was obtained: what symptoms lead to the discovery of the discontinuous device? sharp, severe, generalized abdominal pain, generalized weakness and decreased oral intake x 1 week.When did the symptoms begin? approximately (b)(6) 2022.What was the date of the linx implant procedure? (b)(6) 2018.What is the device lot and serial number? (b)(6).Was the device initially effective in controlling reflux? yes.Were any events associated with the onset of symptoms (vomiting, retching, trauma, surgery)? no.Did the patient undergo an mri since device implant? if so, when was the mri and what strength? yes, (b)(6) 2022- 1.5 tesla.Did the patient have any other surgeries in the area? egd w/removal of food bolus and dilation (b)(6) 2018, egd w/disimpaction of foreign body (b)(6) 2018, egd w/food bolus extraction and dilation (b)(6) 2018, egd w/biopsies (b)(6) 2019, laparoscopic cholecystectomy with intraoperative cholangiogram (b)(6) 2019.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.April 20, 2022- appears to already be discontinuous.Patient had an egd on (b)(6) 2019, for chest pain with concern for linx erosion.He had previously had difficulty with esophageal food boluses and had an episode of severe chest pain, retching and a white count of 18.During the procedure there was no erosion identified.A 360 view of the linx showed no erosion or inflammatory changes at that time.There was no imaging/scopes between (b)(6) 2019 and (b)(6) 2022.Is the explant procedure scheduled? is a replacement linx or fundoplication planned? not yet scheduled, waiting to see if anything can be done about this fractured linx, such as removing it and replacing it at some time down the line.

Manufacturer Narrative

(b)(4); date sent: 1/20/2023.

Manufacturer Narrative

(b)(4).Additional information received: when was the explant date? (b)(6) 2022.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 explanted.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.

• Brand Name: 1.5T LINX, 15B
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4545 creek road; cincinnati OH
• Manufacturer Contact: kate karberg ; 4188 lexington avenue north; shoreview ; 3035526892
• MDR Report Key: 15579747
• MDR Text Key: 301552848
• Report Number: 3008766073-2022-00203
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005356
• UDI-Public: 00855106005356
• 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,Followup
• Report Date: 08/21/2023

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: 04/18/2022
• Device Model Number: LXMC15
• Device Catalogue Number: LXMC15
• Device Lot Number: 19820
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/29/2022
• Initial Date FDA Received: 10/11/2022
• Supplement Dates Manufacturer Received: 11/15/2022; 01/04/2023; 08/21/2023
• Supplement Dates FDA Received: 11/18/2022; 01/20/2023; 08/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention