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

Catalog Number LXMC14

Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Breast Cancer (1759); Vomiting (2144); Hernia (2240)

Event Date 12/08/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent 12/19/2023 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.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.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 is the lot number? what is the date of implant? has the device been explanted? if yes, what was the explant date? by ¿slipped¿ do you mean the device migrated? if no, what is meant by ¿slipped¿? how was the migration of the device diagnosed (chest x-ray, esophageal line at explant)? are there images available that shows the migration? did the patient have a hiatal hernia at the time of implant? if yes was this repaired at this time of implant? does the patient have a re-occurring hernia now? if yes, did the position of the device change based on the hernia reoccurring? 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 the linx slipped and needed to be removed breast cancer patient with chemotherapy.Lots of vomiting with chemo.

Manufacturer Narrative

(b)(4).Date sent: 1/18/2024.Photo images were received.Any additional information obtained from the photo evaluation will be included as part of the product investigation.Additional information received: the patient did have a hiatal hernia at the time of implant and it was repaired at that time.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: how was the migration of the device diagnosed (chest x-ray, esophageal line at explant)? are there images available that shows the migration? please send images to productcomplaint1@its.Jnj.Com.At the time of explant did the patient have a re-occurring hernia? if yes, did the position of the device change based on the hernia reoccurring? b1, b2, h1.Upon review of the additional information it was determined that there was no recurrent hernia upon explant.This file is now usa fda reportable again.

Manufacturer Narrative

(b)(4).Date sent: 1/3/2024.Additional information was requested, and the following was obtained: what is the lot number? 29442 what is the date of implant? (b)(6) 2023.Has the device been explanted? yes.If yes, what was the explant date? (b)(6) 2023.By ¿slipped¿ do you mean the device migrated? the device slipped down to the stomach and caused a partial blockage.If no, what is meant by ¿slipped¿? how was the migration of the device diagnosed (chest x-ray, esophageal line at explant)? upper gi with barium swallow are there images available that shows the migration? the images can be obtained.Did the patient have a hiatal hernia at the time of implant? if yes was this repaired at this time of implant? yes, yes.Does the patient have a re-occurring hernia now? if yes, did the position of the device change based on the hernia reoccurring? yes b1, b2, h1.Upon review of the fiel it was determined that the migration of the linx device was due to the recurrent hernia.Thus the device migrated not due to a product failure but possibly due to a surgical technique error.This file is now usa fda not reportable.

Manufacturer Narrative

(b)(4).Date sent: 2/5/2024.Additional information was requested, and the following was obtained: how was the migration of the device diagnosed (chest x-ray, esophageal line at explant)? are there images available that shows the migration? please send images to productcomplaint1@its.Jnj.Com.At the time of explant did the patient have a re-occurring hernia? if yes, did the position of the device change based on the hernia reoccurring? answer: spoke with dr.Lee and she said that there was no obvious re-occurring hernia but she also didn¿t go look for one either.

Manufacturer Narrative

(b)(4).Date sent: 3/26/2024.Photo review: x-ray images of the device in vivo were reviewed by a medical safety officer.As per medical safety officer: "the images appear to demonstrate an intact linx device located below the diaphragm.Limited contrast images make it difficult to determine if there is a hiatal hernia present." physical analysis: overall review of the device function and dimensions show no anomalies from a device that has been reasonably changed as part of the explant procedure.Visual analysis was consistent with an explanted device, significant tooling marks were noted in some beads.Link length and tensile force were found to meet the applicable specifications.Overall, no analysis conclusions relevant to the patient experience were found.A manufacturing record evaluation was performed for the finished device 29442 number, and no non-conformances related to the malfunction were identified.

• Brand Name: 1.5T LINX, 14B
• 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: 18355981
• MDR Text Key: 330885869
• Report Number: 3008766073-2023-00255
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005349
• UDI-Public: 00855106005349
• 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,Followup
• Report Date: 03/26/2024

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Catalogue Number: LXMC14
• Device Lot Number: 29442
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/09/2023
• Initial Date FDA Received: 12/19/2023
• Supplement Dates Manufacturer Received: 12/21/2023; 01/03/2024; 01/24/2024; 03/25/2024
• Supplement Dates FDA Received: 01/03/2024; 01/18/2024; 02/05/2024; 03/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention