MAUDE Adverse Event Report: TORAX MEDICAL, INC. LINX 1.5 16 BEAD US; ANTI-REFLUX IMPLANT

Catalog Number LXMC16

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 05/24/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.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 is the product code? what is the lot number? what was the implant date? what exactly were the patient symptoms? what is meant by ¿hypersensitivity¿? prior to linx placement, did the patient have an egd, ph, and manometry studies done? if yes, could you please share the results? when using the linx sizing device what technique was used to determine the size? did the patient have an autoimmune disease? were there any intra-operative complications during implant? was there any hiatal or crural repair done at the same time as the implant? were there any other contributing factors that led to the removal of the device other than the reported hypersensitivity? does the patient have any of the allergies to metals? if so, what test have been done to test for metal allergies.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?.

Event Description

It was reported that a linx device was explanted due to hypersensitivity.

Manufacturer Narrative

(b)(4).Date sent: 2/21/2024.Investigation summary: a suture wire knotted on a wire was observed during the visual assessment.It is known that sometimes, during the explant procedure, a suture is placed on the device to aid in the extraction of the device.Hence, it is presumed that the suture was placed by the explant facility during the explant procedure.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.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4) date sent: 2/5/2024 d1, d4.

• Brand Name: LINX 1.5 16 BEAD US
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• Manufacturer Contact: orla o'mahony ; 4188 lexington avenue north; shoreview 55126
• MDR Report Key: 14621265
• MDR Text Key: 293469866
• Report Number: 3008766073-2022-00114
• Device Sequence Number: 1
• Product Code: LEI
• Combination Product (y/n): N
• 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: 02/21/2024

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: LXMC16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/24/2022
• Initial Date FDA Received: 06/07/2022
• Supplement Dates Manufacturer Received: 01/26/2024; 02/06/2024; 02/21/2024
• Supplement Dates FDA Received: 02/05/2024; 02/16/2024; 02/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention