MAUDE Adverse Event Report: TORAX MEDICAL, INC. 1.5T LINX, 15B; ANTI-REFLUX IMPLANT

Catalog Number LXMC15

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Pyrosis/Heartburn (1883); Nausea (1970); Pain (1994)

Event Date 01/01/2024

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 1/25/2024 b3: only event year known: 2024 an analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.However, if the product is received at a later date, the investigation will be updated as applicable.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: is there any pre-op imaging that you can share? productcomplaint1(b)(4).Prior to linx placement, did the patient have an egd, ph, and manometry studies done? if yes, could you please share the results? on what date did the implant take place? on what date did the explant take place? what is the lot number of the linx device? when using the linx sizing device what technique was used to determine the size? did the patient have an autoimmune disease? is the patient currently taking steroids / immunosuppressive drugs? did the patient have any pre-existing dysphagia or other conditions (other than gerd)? how severe was the dysphagia/odynophagia before intervention? 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 acid reflux, nausea, and pain? besides the reported acid reflux, nausea, and pain, what was the reason for removal of the linx device? was the device found in the correct position/geometry at the time of removal? 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

It was reported that during an explant of a linx device, it was observed that the clasp was disconnected.It is unknown if manipulation during removal caused the clasp to disconnect.The wire was cut to facilitate removal and a total of 8 beads including half of the clasp was removed.Extensive exploration did not reveal the remainder of the linx device.Approximately half of the removed device shows dark discoloration.Removal was based on patient complaint of nausea, gerd, and pain.Patient has a history of prior lap sleeve gastrectomy as well as lap hiatal hernia repair.Patient also has a history of tobacco use.Imaging from original implantation confirmed that device was well placed and clasp was secure.

Manufacturer Narrative

(b)(4).Date sent: 2/5/2024.Additional information was requested, and the following was obtained: prior to linx placement, did the patient have an egd, ph, and manometry studies done? if yes, could you please share the results? egd done and a bravo.Manometry could not be tolerated; egd-la grade b,&c, esophagitis; erosion of linx device noted.On what date did the implant take place? implant took place (b)(6) 2022.On what date did the explant take place? explant took place (b)(6) 2024.What is the lot number of the linx device? unknown.When using the linx sizing device what technique was used to determine the size? did the patient have an autoimmune disease? no.Is the patient currently taking steroids / immunosuppressive drugs? no.Did the patient have any pre-existing dysphagia or other conditions (other than gerd)? unknown.How severe was the dysphagia/odynophagia before intervention? unknown.Were there any intra-operative complications during implant? no.Was there any hiatal or crural repair done at the same time as the implant? yes, hiatal and crural repair.Were there any other contributing factors that led to the removal of the device other than the reported acid reflux, nausea, and pain? no.Besides the reported acid reflux, nausea, and pain, what was the reason for removal of the linx device? no.Was the device found in the correct position/geometry at the time of removal? unknown.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: when using the linx sizing device what technique was used to determine the size?.

Manufacturer Narrative

(b)(4).Additional information received: surgeon cut the wire to remove the device and was only able to find and recover the portion that was sent in.The surgeon made a phone call intraoperatively to another linx physician and the feedback was that it would be safe to follow the patient and monitor.At the time of the explant surgery, they would have been present but could not be found and recovered.Expectation is that they may either encapsulate or be passed via natural processes.At the time of the explant surgery, there was no plan to do a subsequent surgery.

Manufacturer Narrative

(b)(4).Photo analysis: an image of the device in vivo was reviewed by a medical safety officer.As per medical safety officer: "looks like a scorched piece if a linx." investigation summary: a partial device (8 beads) was returned in one piece.Visual analysis was consistent with an explanted device, tooling marks were observed in some beads.Link length and tensile force were found to meet the applicable specifications.Only half the clasp (1 bead) was returned for analysis.No issues were observed in the component.Overall, no analysis conclusions relevant to the patient experience were found.

• Brand Name: 1.5T LINX, 15B
• 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: 18580843
• MDR Text Key: 333738708
• Report Number: 3008766073-2024-00016
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005356
• UDI-Public: 00855106005356
• 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,Followup
• Report Date: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: LXMC15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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