MAUDE Adverse Event Report: TORAX MEDICAL, INC. 1.5T LINX, 13B; ANTI-REFLUX IMPLANT

Catalog Number	LXMC13
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Dysphagia/ Odynophagia (1815)
Date of Event	05/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a linx device was explanted due to persistent dysphagia.Unknown what steps were taken prior to the decision to explant.Patients symptoms have resolved since the explant.
Additional Manufacturer Narrative
(b)(4).Date sent: 5/20/2024 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.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.Additional information received: patient did not have any allergies to metal.Patient was not taking any steroids or immunosuppression drugs.Patient did not have any preexisting dysphagia but patient did have conditions other than gerd.Ibs/constipation, interstitial cystitis, depression, generalized anxiety disorder, hyperlipidemia.Patient did have a hiatal/crural hernia repair during implant but mesh was not used.Device was found in the correct position/geometry at the time of removal.Additional information was requested, and the following was obtained: on what date did the implant take place? (b)(6) 2024 does the patient have any of the allergies to metals? if so, what test have been done to test for metal allergies.No is the patient currently taking currently taking steroids / immunosuppressive drugs? no did the patient have any pre-existing dysphagia or other conditions (other than gerd)? no pre-existing dysphagia, ibs/constipation, interstitial cystitis, depression, generalized anxiety disorder, hyperlipidemia was there any hiatal or crural repair done at the same time as the implant? yes was mesh used at time of implant? no what was the reason for removal of the linx device? persistent dysphagia at the time of removal, was the device found in the correct position/geometry at the time of removal? yes have the symptoms resolved since the device was explanted? yes 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.
Additional Manufacturer Narrative
(b)(4).Date sent: 5/24/2024.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? 1.Egd ¿ 2 cm hiatal hernia with a gr 2 valve; bravo demeester score¿ 52.2; manometry ¿ normal.When using the linx sizing device what technique was used to determine the size? 2.Dr.Smith uses the 2 size pop rule, he sizes up 2 when the sizing device pops.Were there any intra-operative complications during implant? 3.No intra-operative complications occurred.A manufacturing record evaluation was performed for the finished device lot number 29069, and no non-conformances were identified.
Additional Manufacturer Narrative
(b)(4).Date sent: 6/17/2024.Investigation summary: 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.A manufacturing record evaluation was performed for the finished device lot number 29069, and no non-conformances were identified.

• Brand Name: 1.5T LINX, 13B
• Common Device Name: 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: 19350552
• Report Number: 3008766073-2024-00088
• Device Sequence Number: 7281281
• Product Code: LEI
• UDI-Device Identifier: 00855106005332
• UDI-Public: 00855106005332
• 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 Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/17/2024

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 Expiration Date: 09/24/2025
• Device Catalogue Number: LXMC13
• Device Lot Number: 29069
• 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: 05/15/2024
• Supplement Date Received by Manufacturer: 05/23/2024; 06/04/2024
• Initial Report FDA Received Date: 05/20/2024
• Supplement Report FDA Received Date: 05/24/2024; 06/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2021
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown