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

Catalog Number	LXMC14
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Device Appears to Trigger Rejection (1524); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Dysphagia/ Odynophagia (1815); Pocket Erosion (2013); Ulcer (2274)
Date of Event	01/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Date sent: 11/12/2024.B3: only event year known: 2024.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.D4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.No lot number was provided therefore a device history could not be done.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 procedure is set to take place in a few weeks and during pre-evaluation the patient had the linx erode to their esophagus.They are going to remove the bead and eventually remove the entire linx in a separate procedure.
Additional Manufacturer Narrative
(b)(4).Date sent 11/26/2024.Additional information was requested, and the following was obtained: update: first procedure complete, occurred on (b)(6).A handful of beads were removed.Customer saved them to collect and send for analysis.A follow up procedure will be scheduled to remove the remaining portion, likely late december & early january.
Additional Manufacturer Narrative
(b)(4).Date sent: 11/21/2024.Corrected data: d1, d4.Additional information was requested, and the following was obtained: what is the product code? was told lxmc14.What is the lot number? not sure.What was the date of implant? not sure of exact date, about a year ago.If the device has been removed, what was the date of explant? if not, what is the expected date of explant? expected within 2 weeks of today.What were the first clinical symptoms that provided evidence of an erosion and when did they first occur? ulcer symptoms has been occurring for a few months before patient announced the issues to their doctor.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.Not disclosed.Are pictures or videos available? no.How many beads eroded? one has been identifed thus far.Where were the eroded beads positioned? not sure yet.Which best describes the device removal approach? endoscopically removed the eroded beads initially & laparoscopically removed the device at a later date.Or, endoscopically removed the entire device (slight possibility).Was the patient stented? not sure yet.What is the current condition of the patient? stable.
Additional Manufacturer Narrative
(b)(4) date sent: 11/25/2024.D6a: exact implant date is unk.File states the implant was 18 months ago.Assumed date is (b)(6) 2023.Additional information was requested, and the following was obtained: what is the product code? was told lxmc14 what is the lot number? not sure what was the date of implant? was just told 18 months ago if the device has been removed, what was the date of explant? if not, what is the expected date of explant? expected within 2 weeks of today.What were the first clinical symptoms that provided evidence of an erosion and when did they first occur? ulcer symptoms has been occurring for a few months before patient announced the issues to their doctor, mild swallowing issues 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.Patient received a scope after reporting symptoms.Are pictures or videos available? no how many beads eroded? one has been identified thus far.Where were the eroded beads positioned? not sure yet which best describes the device removal approach? endoscopically remove the eroded beads initially & laparoscopically remove the device at a later date or endoscopically removed the entire device (slight possibility).Was the patient stented? not sure yet what is the current condition of the patient? stable.
Additional Manufacturer Narrative
(b)(4).Date sent: 12/13/2024.Additional information was requested, and the following was obtained: explant date: (b)(6) (multiple beads were extracted, 5-7).Currently scheduling a follow up procedure to remove rest of beads (if any).

• Brand Name: 1.5T LINX, 14B
• Common Device Name: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4545 creek road; cincinnati OH
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 20665155
• Report Number: 3008766073-2024-00154
• Device Sequence Number: 8502570
• Product Code: LEI
• UDI-Device Identifier: 00855106005349
• UDI-Public: 00855106005349
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P100049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 12/13/2024

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: LXMC14
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/06/2024
• Supplement Date Received by Manufacturer: 11/18/2024; 11/20/2024; 11/22/2024; 12/10/2024
• Initial Report FDA Received Date: 11/12/2024
• Supplement Report FDA Received Date: 11/21/2024; 11/25/2024; 11/26/2024; 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown