MAUDE Adverse Event Report: TORAX MEDICAL, INC. 1.5T LINX, 17 BEADS; ANTI-REFLUX IMPLANT

Catalog Number LXMC17

Device Problems Device Appears to Trigger Rejection (1524); Insufficient Information (3190)

Patient Problems Dysphagia/ Odynophagia (1815); Pain (1994); Insufficient Information (4580)

Event Date 01/01/2024

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 4/18/2024 only event year known: 2024 an analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.However, if the product is received at a later date, the investigation will be updated as applicable.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 reason for the initial surgery? please give us more detail on the indication of the removal.Please provide what is meant by the esophagus was attached to the chest? can we please receive the op notes if available.How was it determined that the esophagus was attached to the chest of the patient? if photos are available, please send to productcomplaint1@its.Jnj.Com on what date did the implant take place? lot #? does the patient have any of the allergies to metals? if so, what test have been done to test for metal allergies.Is the patient currently taking currently taking steroids / immunosuppressive drugs? did the patient have any pre-existing dysphagia or other conditions (other than gerd)? was there any hiatal or crural repair done at the same time as the implant? was mesh used at time of implant? at the time of removal, was the device found in the correct position/geometry at the time of removal? have the symptoms resolved since the device was explanted? 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 was removed on (b)(6) 2024.There was nothing wrong with the linx and the patient.The reason for removal was because when they operated, the esophagus was attached to chest of the patient and they were trying to mobilize but couldn't which made them remove it.They were worried the patient was going to suffer a stroke from being under the anesthesia for too long and the plan was originally preserve the linx but was forced to this scenario due to her anatomy.

Manufacturer Narrative

(b)(4) date sent: 4/30/2024 additional information was requested, and the following was obtained: when asked the question when was the implant date.The answer was on (b)(6) 2024.We have on (b)(6) 2024 as the explant date.When was the implant date? surgeon did not provide, will inquire when was the explant date? 4/5, my apologies for the confusion.

Manufacturer Narrative

(b)(4) date sent: 4/29/2024 additional information was requested, and the following was obtained: what was the reason for the initial surgery? reflux please give us more detail on the indication of the removal.Pain & dysphasia please provide what is meant by the esophagus was attached to the chest? surgeon stated that she needed to mobilize the esophagus but was able to because to was adhesed to the chest wall.Can we please receive the op notes if available.Will inquire how was it determined that the esophagus was attached to the chest of the patient? during the operation.Initial plan was to preserve the linx.However, the due to the challenging location of the esophagus, she was unable to mobilize it enough to preserve linx.Patient was also under anesthesia for substantial time and had a stroke previously, this made decision to remove linx.Surgeon confirmed, the anatomical challenges had nothing to with linx.However it was causing pain for patient to swallow due to the location of esophagus.If photos are available, please send to (b)(6) on what date did the implant take place? on (b)(6) 2024.Lot #? do not have does the patient have any of the allergies to metals? no if so, what test have been done to test for metal allergies.Is the patient currently taking currently taking steroids / immunosuppressive drugs? unsure , will inquire did the patient have any pre-existing dysphagia or other conditions (other than gerd)? pain & dysphasia was there any hiatal or crural repair done at the same time as the implant? will inquire was mesh used at time of implant? will inquire at the time of removal, was the device found in the correct position/geometry at the time of removal? yes have the symptoms resolved since the device was explanted? patient is doing ok according to surge on 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: when asked the question when was the implant date.The answer was on (b)(6) 2024.We have on (b)(6) 2024 as the explant date.When was the implant date? when was the explant date?.

Manufacturer Narrative

(b)(4).Date sent: 5/14/2024.Additional information was requested, and the following was obtained: what is the implant date? implant (b)(6) 2023.

• Brand Name: 1.5T LINX, 17 BEADS
• 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: 19137854
• MDR Text Key: 340561820
• Report Number: 3008766073-2024-00066
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005370
• UDI-Public: 00855106005370
• 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: 05/14/2024

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 Catalogue Number: LXMC17
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/15/2024
• Initial Date FDA Received: 04/18/2024
• Supplement Dates Manufacturer Received: 04/25/2024; 04/26/2024; 05/10/2024
• Supplement Dates FDA Received: 04/29/2024; 04/30/2024; 05/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention