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

Model Number LXMC16

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Pyrosis/Heartburn (1883); No Code Available (3191)

Event Date 07/17/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.Per photographic evaluation: review of an xray image depicting the lower thoracic area of a patient.There was an intact linx device seen in the image.No issues were noted based on the ethicon medical safety officer¿s analysis of the image.The dhr for lot 20398 was reviewed.No defects, ncrs, or reworks related to the product complaint were found.Lot 20398 was an affected lot of the 2018 linx recall.Additional information: note on patient history: patient had failed nissen prior to linx placement.Patient had lxmc17 placed on (b)(6) 2017.Patient had symptomatic recurrence of hernia (return of reflux symptoms & positive demester score).Lxmc17 was removed and replaced with lxmc16 on (b)(6) 2018.Stomach was found to have herniated through linx device.What was the reason for removal of the linx device? recurrent reflux symptoms (demester score: 56).Does the patient have any of the allergies to metals? no.Is the patient currently taking currently taking steroids / immunization drugs? unknown.Did the patient have any pre-existing dysphagia or other conditions (other than gerd)? unknown.Was there any hiatal or crural repair done at the same time as the implant? yes.Was mesh used at time of implant? no.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? unknown¿device was removed today.What is the product code? lxmc16.What is the lot number? 20398.The following information was requested, but unavailable: was ph testing performed prior to explant to confirm recurrent reflux? when did the recurrent reflux begin? in the event description it states: ¿patient was placed on medical therapy¿.What is was the medical therapy? 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 strength of the mri that was performed?.

Event Description

It was reported that the patient had lxmc16 placed on (b)(6) 2018.Had mri on (b)(6) 2019.Two weeks after mri experienced new onset recurrence of reflux symptoms.Patient was placed on medical therapy.When symptoms did not resolve they had diagnostic workup (manometry, ph test, upper gi).Testing showed linx in normal position, normal motility, positive demeester score of 56.Patient was scheduled for linx removal.On (b)(6) 2020 the lxmc16 was removed.Esophagus was sized and new lxmc was placed.Of note in the procedure the surgeon used endoflip to measure distensibility with old linx in place prior to removal.Distensibility index was 4.5 (incompetent les).New linx was paced just above scar capsule of old device and endoflip measured distensibility index of 0.9.These measurements caused surgeon to believe the old linx was malfunctioning.

Manufacturer Narrative

(b)(4).Date sent: 9/11/2020.Device analysis: 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, and link length and tensile force were found to meet the applicable specifications.Overall, no analysis conclusions relevant to the patient experience were found.

• Brand Name: LINX 1.5 16 BEAD US
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 10396045
• MDR Text Key: 202953529
• Report Number: 3008766073-2020-00120
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005363
• UDI-Public: 00855106005363
• Combination Product (y/n): N
• PMA/PMN Number: P100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 07/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/27/2022
• Device Model Number: LXMC16
• Device Catalogue Number: LXMC16
• Device Lot Number: 20398
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2020
• Date Manufacturer Received: 08/18/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention