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

Model Number LXMC14

Device Problem Structural Problem (2506)

Patient Problems Dysphagia/ Odynophagia (1815); Pneumonia (2011); Vomiting (2144); Hernia (2240); No Code Available (3191)

Event Date 02/17/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: (b)(6) 2020.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.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.Was the device initially effective in controlling reflux? were any events associated with the onset of symptoms (vomiting, retching, trauma, surgery)? did the patient have any other surgeries in the area? was any additional imaging performed since device implant? does the device appear to be in a continuous annular state in these images? we are interested in establishing a window when the device may have become discontinuous.Please share any additional images.Is the device available for return? if yes, please provide the contact name and mailing address for the return kit.

Event Description

It was reported that post implant, a linx was removed by the doctor.Device appears to be separated with weldball visible on end of wire and out of bead case.Egd 12/2019¿small hiatal hernia, device in appropriate location, appears intact.Symptoms of persistent cough and recurring aspiration pneumonia.No mri since implantation.Dor fundo done at time of removal.It is unknown if there were any adverse consequences to the patient.

Manufacturer Narrative

(b)(4).Date sent: 04/29/2020.Device analysis: the visual analysis found that the returned device had an exposed well ball paired with the washer side of the adjacent bead.The affected washer through hole diameter was measured with computed tomography (ct) and found to be greater than the specification.A slight rim of material was noted on the outer edge of the through-hole.No conclusions could be made whether the irregular shape of the through-hole was a result of the machining process at the component supplier, forces applied during use by the patient, or forces applied during the implant/explant procedures.The exposed weld ball diameter was found to meet specifications.The interference between the washer through-hole and the exposed weld ball diameters was 0.0007".It is presumed that a certain geometric combination of the weld ball and the washer through-hole resulted in the device separation in vivo.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.The dhr for lot 8100 (serial number (b)(6) was reviewed.No defects, ncrs, or reworks related to the product complaint were found.Lot 8100 was an affected lot of the 2018 linx recall.

Manufacturer Narrative

(b)().Date sent: 02/22/2020.Per video evaluation: per ethicon medical safety: i reviewed a video clip of the explant procedure for this patient.The capsule over the line device was excised anteriorly and the line device clasp was mobilized free from the capsule.The linx wie just to the right of the clasp was cut with laparoscopic wire cutter.The surgeon then excised the capsule over each bead and began removed a segment of the device which was 6 beads in length.The device was obviously discontinuous as there was evidence of loss of continuity of the device after 6 beads were removed.The linking wire was seen free from the washer, consistent with pull through.The surgeon then removed the remaining discontinuous beads which totaled 8 in number.

Manufacturer Narrative

(b)(4).Date sent: 03/31/2020.Additional information was requested, and the following was obtained: pd, male, implant (b)(6) 2016.Prior to surgery his number one symptom was cough and recurrent aspiration pneumonia.His coughing and aspiration pneumonia episodes stopped for three years.About six months ago these recurred.He now describes frequent coughing and throat clearing.He has had several episodes of aspiration pneumonia and is now back on omeprazole.He has occasional regurgitation and intermittent mild dysphagia.Workup: egd (b)(6) 2019.Impression: small hiatal hernia; appropriate position of msa device; intact appearing msa device.Ph (b)(6) 2019 off ppi, demeester 24.0 indications persistent cough symptoms despite prior linx procedure.Interpretations the patient has abnormal upright, normal supine, and abnormal total acid exposure.Some reflux events are seen to extend to the level of the ues (see example).A large number of episodes of aerophagia are noted (see example), that were incorrectly interpreted as gas reflux events by the software.No specific event times were logged to allow calculation of a symptom index.Manometry (b)(6) 2019.Post-procedure diagnoses: esophageal motor disorder; hiatal hernia; hypotensive lower esophageal sphincter.Additional esophageal manometry study comments: the patient has a minor motor disorder, characterized by fragmented or failed peristalsis, resulting in incomplete bolus clearance; the combination of hypotonic les and separation of the les region from the level of the respiratory inversion point, frequently results in re-reflux of cleared bolus back into the esophageal lumen after the peristaltic wave passes, as seen below (yellow arrows); there is normal deglutitive inhibition during the rapid drinking test.No mri removed device, toupet on (b)(6) 2020.

• Brand Name: 1.5T LINX, 14B
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 9799734
• MDR Text Key: 185660912
• Report Number: 3008766073-2020-00041
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/18/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/04/2019
• Device Model Number: LXMC14
• Device Catalogue Number: LXMC14
• Device Lot Number: 8100
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/10/2020
• Initial Date Manufacturer Received: 02/18/2020
• Initial Date FDA Received: 03/06/2020
• Supplement Dates Manufacturer Received: 03/10/2020; 04/01/2020; 04/28/2020
• Supplement Dates FDA Received: 03/31/2020; 04/22/2020; 04/29/2020
• Removal/Correction Number: Z-2038-2018
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention