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 Problem Pyrosis/Heartburn (1883)

Event Date 01/22/2024

Event Type  Injury  

Event Description

It was reported that a linx was explanted.The device was thought to be discontinuous and the patient's gerds symptoms back.

Manufacturer Narrative

(b)(4).Date sent: 2/5/2024.Lot number was received and dhr is pending review.When the review is completed, a supplemental medwatch will be sent with a summary of 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 was the date of the imaging which showed the discontinuous linx? if available, please share a copy of this imaging.Please send to: (b)(4).Was the device initially effective in controlling reflux? were any events associated with the onset of symptoms (vomiting, retching, trauma, surgery)? did the patient undergo an mri since device implant? if so, when was the mri and what strength? did the patient have any other surgeries in the area? was any additional imaging performed since device implant? does the device appear to be in a continuous annular state in these images? we are interested in establishing a window when the device may have become discontinuous.Please share any additional images.What is the management plan? is a replacement linx or fundoplication planned? when and if the linx device is removed, may we ask that the device be returned for analysis? was ph testing performed prior to explant to confirm recurrent reflux? when did the recurrent reflux begin? 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.

Manufacturer Narrative

(b)(4).Date sent: 3/13/2024.Photo analysis: a photo of the device in vivo was reviewed by a medical safety officer.As per medical safety officer: "the intraoperative photo reviewed shows a linx device being removed laparoscopically.The device appears discontinuous." the mechanism/cause of failure is unknown.The physical device was received and further investigation is in progress.A manufacturing record evaluation was performed for the finished device 23897 number, and no non-conformances related to the malfunction were identified.Investigation summary: a linx device with a visible weld ball that disconnected from a male bead case was returned to the analysis site.The link length and tensile force measurements were found to meet the applicable specifications during device analysis.The remaining device characteristics, excepting the visible weld ball, show no anomalies for a device that has been reasonably changed as part of the explant procedure, tooling marks were noted in some beads.The device was scanned using computer tomography (ct), optical microscopy, and scanning electron microscopy.The male bead case at the separation was measured and was greater than the specification.The male bead case was concentric with small amount of material displacement at the outer edge of the through hole.The overall appearance of the surface of the male bead case through hole didn¿t exhibit gross loss of shape.The top view of the diameter of the exposed weld ball was measured.This diameter is within the specification.The weld ball was concentric with the respect to the wire.

Manufacturer Narrative

(b)(4).Date sent: 2/22/2024.Photo images were received.Any additional information obtained from the photo evaluation will be included as part of the product investigation.Additional information was requested, and the following was obtained: was the device initially effective in controlling reflux? yes.Were any events associated with the onset of symptoms (vomiting, retching, trauma, surgery)? no.Did the patient undergo an mri since device implant? if so, when was the mri and what strength? unknown.Did the patient have any other surgeries in the area? no.Was any additional imaging performed since device implant? does the device appear to be in a continuous annular state in these images? we are interested in establishing a window when the device may have become discontinuous.Please share any additional images.Unknown.What is the management plan? is a replacement linx or fundoplication planned? replacement linx when and if the linx device is removed, may we ask that the device be returned for analysis? it was returned.Was ph testing performed prior to explant to confirm recurrent reflux? yes.When did the recurrent reflux begin? unknown.

• 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: 18639704
• MDR Text Key: 334528882
• Report Number: 3008766073-2024-00026
• 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
• Report Date: 03/13/2024

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
• Device Operator: Health Professional
• Device Expiration Date: 10/30/2022
• Device Catalogue Number: LXMC14
• Device Lot Number: 23897
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/23/2024
• Initial Date FDA Received: 02/05/2024
• Supplement Dates Manufacturer Received: 02/12/2024; 03/11/2024
• Supplement Dates FDA Received: 02/22/2024; 03/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2018
• 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