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

Catalog Number LXMC14

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 Asthma (1726); Autoimmune Disorder (1732); Breast Cancer (1759); Pyrosis/Heartburn (1883); High Blood Pressure/ Hypertension (1908); Hernia (2240); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 09/06/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 09/19/2023.B3: unknown; captured as awareness date.Investigation summary an analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.However, if the product or product id numbers are received at a later date, the investigation will be updated as applicable.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

A surgery was performed on a 65 yo female patient with history of hypertension, nocturnal reflux, gerd, hiatal hernia, asthma, lupus and mitral valve prolapse.Patient had linx implanted to treat gerd and she did well with the implant until reflux symptoms returned four years later and imaging reveals a discontinuous device.Patient has also been diagnosed with breast cancer and underwent mastectomy earlier this year.Patient plans to undergo fundoplication after her breast reconstruction as proton pump inhibitor is partially working at this time.

Manufacturer Narrative

(b)(4).Date sent: 9/28/2023.H6.Health effect - impact code f19.

Manufacturer Narrative

(b)(4).Photo analysis: x-ray images of the device in vivo were reviewed by a medical safety officer.As per medical safety officer: "the images (pa & lat cxr) demonstrate a linx device that appears intact and is located below the diaphragm." the mechanism/cause of failure is unknown as a hands-on analysis of the device is necessary to determine the cause of failure.No further investigation can be completed at this point.

Manufacturer Narrative

(b)(4).Date sent: 11/8/2023.See op notes.

Manufacturer Narrative

(b)(4).Date sent: 1/12/2024.D6b: exact date is unk.For now 12/11/2023 has been added.When the exact date is known the file will be updated and a correction mw sent, if necessary.Additional information received: 12/18/23 received confirmation from counsel for patient that device was explanted last week.Pre operative imaging demonstrated the device was intact prior to explant.

Manufacturer Narrative

(b)(4).Date sent: 5/1/2024.Additional information received: after multiple attempts, the attorney has not responded or provided the device or explant records.It appears they no longer plan to pursue this matter as the device was intact in imaging.

• 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 ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 17777204
• MDR Text Key: 323768209
• Report Number: 3008766073-2023-00184
• Device Sequence Number: 1
• Product Code: LEI
• 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: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/01/2024

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 Catalogue Number: LXMC14
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/06/2023
• Initial Date FDA Received: 09/19/2023
• Supplement Dates Manufacturer Received: 09/19/2023; 10/30/2023; 11/30/2023; 12/18/2023; 05/01/2024
• Supplement Dates FDA Received: 09/28/2023; 11/08/2023; 12/11/2023; 01/12/2024; 05/01/2024
• 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
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 103 KG