MAUDE Adverse Event Report: TORAX MEDICAL, INC. 1.5T LINX, 14B; ANTI-REFLUX IMPLANT

Model Number LXMC14

Device Problems Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Pyrosis/Heartburn (1883); High Blood Pressure/ Hypertension (1908); Weight Changes (2607)

Event Date 02/04/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Unknown; captured as awareness date.Exact day of implant date is unknown.Assumed 1st day of the month.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.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 symptoms lead to the discovery of the discontinuous device? when did they begin? what was the date of the imaging which showed the discontinuous linx? if available, please share a copy of this imaging.Were any events associated with the onset of symptoms (vomiting, retching, trauma, surgery)? did the patient have any other surgeries in the area? it was reported that chest x-rays in 2018, 2019 and 2020 all show an intact linx device.Haw there been any recent imaging that shows the discontinuity.If yes, could that image be shared with us? the patient was scheduled for a marshmallow test on (b)(6).Can the findings of this test be shared with us? what is the management plan? is device removal scheduled? is a replacement linx or fundoplication planned? when and if the explanation takes place can we ask that the procedure gets video recorded and the video shared? when and if the linx device is removed, may we ask that the device be returned for analysis? 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 the patient was implanted with linx 3/2017, has had good reflux control until recently.Esophagram shows possible discontinuity.Now has reflux symptoms, on ppi daily, losing weight and has elevated bp.No history of trauma to that area nor mri.Chest x-rays 2018, 2019, 2020 all show intact device.Patient scheduled for a marshmallow swallow 2/10 to confirm discontinuity.Surgery date tbd.

Manufacturer Narrative

(b)(4).Date sent: 3/30/2022.Investigation summary: the visual analysis found that the returned device had an exposed well ball paired with the washer trough hole of the adjacent bead.The affected washer through hole diameter was measured with computed tomography (ct) and was found to be greater than the specification.The washer through hole had small amount of material displacement at the outer edge of the through hole.The overall appearance of the surface of the washer didn't exhibit gross loss of shape.Top view of the diameter of the exposed weld ball was measured.This diameter is within the specification.Review of the device dimensions at the failed junction showed a larger that specification washer through hole diameter and a within specification weld ball.It is presumed that geometric combination of the through hole and weld ball led to the discontinuity of the device.The link length and tensile force were found to meet the applicable specifications.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.

Manufacturer Narrative

(b)(4).Date sent: 3/16/2022.Photo analysis: as per medical safety officer: the image demonstrates a discontinuous device.The mechanism/cause of failure cannot be determined from the provided images/videos.The dhr for lot 12929 was reviewed.No defects, ncrs, or reworks related to the product complaint were found.Lot 12929 was an affected lot of the 2018 linx recall additional information provided: updated image during a recent barium swallow for this patient.The initial imaging was not as clear as this as to the possibility of discontinuity.The removal/linx replacement is scheduled on (b)(6), 2022.Received message from surgeon¿s office who advised that patient¿s explant procedure has been moved and will take place tuesday, 3/8.

• Brand Name: 1.5T LINX, 14B
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• Manufacturer Contact: kara ditty-bovard ; 4188 lexington avenue north; shoreview 55126 ; 6107428552
• MDR Report Key: 13580076
• MDR Text Key: 290044527
• Report Number: 3008766073-2022-00039
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005349
• UDI-Public: 00855106005349
• 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
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 03/30/2022

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: 11/21/2020
• Device Model Number: LXMC14
• Device Catalogue Number: LXMC14
• Device Lot Number: 12929
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/04/2022
• Initial Date FDA Received: 02/22/2022
• Supplement Dates Manufacturer Received: 02/28/2022; 03/18/2022
• Supplement Dates FDA Received: 03/16/2022; 03/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/21/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: Z-2038-2018
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention