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

Catalog Number	LXMC16
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Heartburn/Indigestion (1883)
Date of Event	11/08/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Date sent: 11/20/2023.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.Photo images were received.Any additional information obtained from the photo evaluation will be included as part of the product investigation.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 implant? when did the recurrent gerds begin? what was the date of the imaging which showed the discontinuous linx? what is the product code? what is the device lot number? 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.How was the migration of the device diagnosed (chest x-ray, esophageal line at explant)? are there images available that shows the migration? did the patient have a hiatal hernia at the time of implant? if yes was this repaired at this time of implant? does the patient have a re-occurring hernia now? if yes, did the position of the device change based on the hernia reoccurring? 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 patient had a linx implanted years ago.She has recurrent gerd and the linx is migrated into the chest.She had an x-ray in february with the device intact.Yesterday she got her pre op ugi and the linx is now disrupted.No change in symptoms.She doesn't quality for another linx because of severe iem.
Additional Manufacturer Narrative
(b)(4).Photo analysis: an x-ray image of the device in vivo was reviewed by a medical safety officer.As per medical safety officer: "the images reviewed them straight what appears to be a discontinuous linx device." 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.
Additional Manufacturer Narrative
(b)(4) date sent: 4/11/2024 investigation summary a linx device with a visible weld ball that disconnected from a washer 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, significant tooling marks were noted in some beads.The device was scanned using computer tomography (ct), optical microscopy, and scanning electron microscopy.The washer through-hole at the separation was measured and was greater than the specification.The washer through-hole was concentric with small amount of material displacement at the outer edge of the through hole.The overall appearance of the surface of the washer 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.
Additional Manufacturer Narrative
(b)(4).Date sent: 1/3/2024.Additional information received: the product code should be lxmc16.D1, d4.

• Brand Name: LINX 1.5 16 BEAD US
• 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: 18169836
• Report Number: 3008766073-2023-00232
• Device Sequence Number: 15352859
• Product Code: LEI
• UDI-Device Identifier: 00855106005363
• UDI-Public: 00855106005363
• 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 Explanted Year: 2023
• 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
• Report Date (Section B): 04/11/2024

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: LXMC16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/08/2023
• Supplement Date Received by Manufacturer: 12/05/2023; 12/20/2023; 04/08/2024
• Initial Report FDA Received Date: 11/20/2023
• Supplement Report FDA Received Date: 12/11/2023; 01/03/2024; 04/11/2024
• 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 Sex: Unknown