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

Catalog Number LXM16

Device Problems Migration or Expulsion of Device (1395); Patient Device Interaction Problem (4001)

Patient Problem Hernia (2240)

Event Date 03/13/2024

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 4/1/2024.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.Additional information received: a device explant has been reported.Please review this event as soon as possible.Event details: alert date: (b)(6) 2024.Date of explant:(b)(6) 2024.Country of event: (b)(6).Model: lxm16.Device lot number: 26626.Date of implant: (b)(6) 2021.Patient details: patient identifier: (b)(6).Sex: male.Age (at time of consent): 37 years.Additional event details: was the linx explant a result of an adverse event per protocol definitions?: no if yes, choose the primary ae log line, start date and term: blank.If no, what was the reason for the explant? (check all that apply).Participant had anxiety about implant: no medical need for high field strength mri or other testing: no participant wishes to have alternative gerd treatment requiring linx explant: no continued gerd symptom: no did not meet participant expectations: no other: yes if other, specify: large recurrence diaphragmatic hernia post linx ((b)(6)).Describe the technique used for explant (check all that apply).Laparoscopic: yes.Endoscopic: no.Other: no.If other, specify: blank.Were any concomitant procedures performed?: yes describe any notable observations during the explant procedure: large near total recurrence of gastric herniation into the chest.Hiatal defect 10cm.Linx located above diaphragm.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 country is this file from? what was the reason for removal of the linx device? at the time of removal, was the device found in the correct position/geometry at the time of removal? have the symptoms resolved since the device was explanted? 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 via clinical trial patient (b)(6) experience, linx explant.Relationship to study device: not provided.

Manufacturer Narrative

(b)(4).Date sent: 5/16/2024.A manufacturing record evaluation was performed for the finished device 26626 number, and no non-conformances related to the malfunction were identified.

Manufacturer Narrative

(b)(4) date sent: 5/23/2024 h12: corrected data: b1, b3, h1 additional information was requested, and the following was obtained: at the time of explant surgery was the position of the device relative to the ge junction? it was at the ge junction which itself had herniated into the chest.Does the surgeon believe that it was in the original site of original implantation? yes.What was the reason for removal of the linx device? pt had developed a large diaphragmatic recurrence therefore the linx was removed and a fundoplication carried out with re-repair of diaphragm defect and a gastropexy to prevent reflux.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? his hernia has been corrected but he has side effects of a reoperation namely gastric stasis due to vagal nerve dysfunction.Please note : all his recurrent condition has no direct relation to the linx device but is due to failure of the diaphragm to hold suture repair.Pt job involved lifting heavy weights after surgery which probably resulted in breakdown of hiatal repair.Upon review of the information provided, it was concluded that this event does not meet the fda defined criteria for a reportable event and is being considered not reportable.B1, b3, h1 upon review of the information provided, it was concluded that this event does not meet the fda defined criteria for a reportable event and is being considered not reportable.

• Brand Name: LINX 1.5T 16 BEAD OUS
• 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: 19014558
• MDR Text Key: 339083329
• Report Number: 3008766073-2024-00052
• Device Sequence Number: 1
• Product Code: LEI
• 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: Foreign,Study
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/23/2024

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: 01/31/2024
• Device Catalogue Number: LXM16
• Device Lot Number: 26626
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/13/2024
• Initial Date FDA Received: 04/01/2024
• Supplement Dates Manufacturer Received: 05/16/2024; 05/20/2024
• Supplement Dates FDA Received: 05/16/2024; 05/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2020
• 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
• Patient Age: 37 YR
• Patient Sex: Male