MAUDE Adverse Event Report: TORAX MEDICAL, INC. 1.5T LINX, 15B; ANTI-REFLUX IMPLANT

Catalog Number	LXMC15
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Pocket Erosion (2013)
Date of Event	01/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Date sent: 4/22/2024 b3: only event year known: 2024 no lot number was provided therefore a device history could not be done.Additional information received: egd 1/12/24 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 or Problem Description
It was reported that a linx has eroded.
Additional Manufacturer Narrative
(b)(4).Date sent: 5/2/2024 additional information was requested, and the following was obtained: what is the lot number? what was the date of implant? what was the date of explant? what were the first clinical symptoms that provided evidence of an erosion and when did they first occur? has the patient had any dilations, egd, or other procedure between the linx implant and discovery of the erosion? please describe and include the dates of the procedures.Are pictures or videos available? how many beads eroded? where were the eroded beads positioned? which best describes the device removal approach? endoscopically removed the eroded beads initially & laparoscopically removed the device at a later date endoscopically removed the eroded beads & laparoscopically removed the device the same day endoscopically removed the entire device laparoscopically removed the entire device was the patient stented? what is the current condition of the patient? answer: there is no other information available from the customer.
Additional Manufacturer Narrative
(b)(4).Date sent: 5/16/2024.Investigation summary: 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, 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.

• Brand Name: 1.5T LINX, 15B
• Common Device Name: 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: 19151798
• Report Number: 3008766073-2024-00071
• Device Sequence Number: 21189481
• Product Code: LEI
• UDI-Device Identifier: 00855106005356
• UDI-Public: 00855106005356
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P100049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/16/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: LXMC15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/19/2024
• Supplement Date Received by Manufacturer: 05/02/2024; 05/14/2024
• Initial Report FDA Received Date: 04/22/2024
• Supplement Report FDA Received Date: 05/02/2024; 05/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 73 KG