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

Model Number LXMC16

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Dysphagia/ Odynophagia (1815); Pyrosis/Heartburn (1883); Hernia (2240)

Event Date 01/08/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 12/18/2019.The dhr for lot 22859 was reviewed.No ncs, reworks, or defects were found.Additional information: does the patient have an autoimmune disease? no.Are they currently taking steroids / immunization drugs? no.Have they scheduled an appointment with a physician who will address any symptoms the subject is experiencing with regard to the linx device? yes, subject is in a clinical trial and will be seen again at the 12-month follow-up window between 09nov2019 ¿ 08mar2020.Will the linx device be explanted? no plans to do this at this time.Visit date: (b)(6).Emot now shows hh and hypotensive les.Bravo is positive for severe reflux.Egd shows hh and severe esophagitis.She is taking a long time to eat.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.How was the migration of the device diagnosed (chest x-ray, esophageal line at explant)? are there images available that shows the migration? does the surgeon believe that the choking could have correlated to the device migration? is the famotidine 20mg per day prescription based or over the counter? prior to linx placement, did the patient have an egd, ph, and manometry studies done? if yes, could you please share the results? when using the linx sizing device what technique was used to determine the size? did the patient have any pre-existing dysphagia or other conditions (other than gerd)? how severe was the dysphagia/odynophagia before intervention? were there any intra-operative complications during implant? was there any hiatal or crural repair done at the same time as the implant? were there any other contributing factors that led to the removal of the device other than the reported dysphagia? where facility was the device implanted?.

Event Description

It was reported that post-implant of a linx device on (b)(6) 2019, subject had been without any gerd symptoms until early (b)(6) 2019 when subject choked hard while eating a pecan.Since that time, subject had mild heartburn which is well controlled with one 20mg famotidine tablet daily.Subject had an esophagram on (b)(6) 2019 which showed no evidence of obstruction, leak or reflux but did show ¿mild hold up of contrast¿ at distal esophagus.Symptoms are ongoing.Subject experience dyspepsia.Device remains implanted.

Manufacturer Narrative

(b)(4).Date sent: 01/10/2020.Additional information received: during the months that followed, heartburn symptoms became progressively worse.Famotidine was increased to 20mg 2x daily on (b)(6) 2019.Esophagitis diagnosed on (b)(6)2019.Medications - famotidine 40 mg qd, carafate 1 gm 4x qd.Esophagram on (b)(6) 2019 ¿ no obvious hiatal hernia present.Heartburn symptoms became progressively worse despite 40 mg famotidine daily.12-month visit esophagram showed hiatal hernia above the level of the linx.12-month egd showed 2 cm hh and severe esophagitis.Moderate - discomfort intense enough to cause interference with usual activities.Interventions: 40mg famotidine bid, carafate 1-gram qid.No hospitalization.At the end on (b)(6) 2019, reported that she had increased her famotidine to twice daily for a total of 40mg per day as her reflux was waking her up at night.Symptoms continued.On (b)(6) 2019, subject began undergoing study required 12-month testing.Subject had chest x-rays and esophagram with barium on (b)(6) 2019.Per radiologist, the x-ray showed linx device was at a stable position at the ge junction as compared to prior x-ray.Esophagram showed hiatal hernia above level of linx with evidence of reflux (via contrast).Subject also underwent manometry testing on (b)(6) 2019.Overall the subject was noted to have a hypotensive les and small hiatal hernia.On (b)(6) 2019, the subject had an egd and bravo capsule placed.Egd showed severe esophagitis and a 2cm hiatal hernia.Surgeon would like the subject to lose weight in preparation for surgical hernia repair with or without linx removal.Subject planning to have surgery on (b)(6) 2020.Implanted at (b)(6) center.How was the migration of the device/re-herniation diagnosed (chest x-ray, esophageal line at explant)? at present, device is still implanted.Re-herniation was diagnosed through esophagram and egd.Between egd and esophagram, the linx is in steady position from the time of placement.The linx has remained in the same position, however the top portion of stomach has herniated through it into the chest.Are there images available that shows the migration/re-herniation? site will send esophagram and egd report.Does the surgeon believe that the choking could have correlated to the device migration/re-herniation? yes, surgeon believes choking may be root cause.There is no other identifiable cause.Is the famotidine 20mg per day prescription based or over the counter? prescription based.Subject is now taking 40mg once per day prior to linx placement, did the patient have an egd, ph, and manometry studies done? yes when using the linx sizing device what technique was used to determine the size? surgeon used the standard sizer and pop off method used for all cases as recommended by the company.Did the patient have any pre-existing dysphagia or other conditions (other than gerd)? no active problems at time of screening: bariatric surgery, bilateral carpel tunnel, gerd without esophagitis and hypoglycemia.Clinic note dated on (b)(6) 2018, stated dysphagia with some foods (dry meats does not go down well), eats healthy but sometimes food feels stuck.This was mostly due to poor food choices and more related to sleeve than linx.How severe was the dysphagia/odynophagia before intervention? subject self-reported severe difficulty swallowing once per day at the location of the esophagus.Most bothersome symptoms for subject were chest pain, regurgitation and heartburn per the foregut symptom questionnaire.Were there any intra-operative complications during implant? no.Was there any hiatal or crural repair done at the same time as the implant? yes, hiatal hernia repair.Were there any other contributing factors that led to the removal of the device other than the reported dysphagia? currently, device is in place.Plan is to keep it in place and reposition after herniated stomach brought below the diaphragm.

Manufacturer Narrative

(b)(4).Date sent: 02/03/2020.The dhr for lot: 22859 was reviewed.No ncs, reworks, or defects were found.Additional information received: 12 month f/u information provided: sleeve gastrectomy: surgery date: 2008.Patient is 11 months after linx and hhr.S/p linx and hhr jan.8, 2019.She had improvement of symptoms since her operation 11 months ago.Emot now show hh and hypotensive les.Bravo is positive for severe reflux.Egd shows hh and severe esophagitis.She is taking a long time to eat.Active problems: bariatric surgery status.Bilateral carpal tunnel syndrome.Dysphagia.Fatty liver.Gert.Glucose intolerance.Hyperlipidemia.Hypertension, unspecified type.Hypoglycemia.Numbness.Obesity.S/p laparoscopic sleeve gastrectomy.Trigger middle finger of right hand.X-ray (no image provided) chest 2 view pa and lat: on (b)(6) 2019.Result: 1.Stable appearance of gastroesophageal sphincter augmentation device with stable positioning at the expected location of the ge junction.2.No acute cardiopulmonary process.Barium esophagram gi esophagram: on (b)(6) 2019.S/p linx device placement.Findings: the oral phase of swallowing was well-coordinated and strong.There was no aspiration, penetration of the airway, or nasopharyngeal reflux.There was no esophageal stricture or ulcer or mass.Linx device in stable position as compared to prior.There was a normal esophageal peristalsis.There is a hiatal hernia above the level of the linx with evidence of contrast reflux.Manometry (esophageal): on (b)(6) 2019.Impression: hypotensive lower esophageal sphincter.Normal esophageal manometry.Upper gi endoscopy: on (b)(6) 2019.Impression.Moderately severe reflux esophagitis.Biopsied.Z-line regular, 34 cm from the incisors.2 cm hiatal hernia.A sleeve gastrectomy was found.Normal examined duodenum.Appears that an additional narrowing is present below ge junction consistent with portion of stomach slipping above the linx device.Bravo capsule in adequate position.Bravo: on (b)(6) 2019.Originally categorized as dyspepsia and now has been changed to esophagitis, (re-herniation).Subject was hospitalized for revision surgery for a re-herniation of the hiatus.The linx was not explanted.

• 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: 9491930
• MDR Text Key: 173700004
• Report Number: 3008766073-2019-00561
• 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,Followup
• Report Date: 12/05/2019

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: 10/22/2022
• Device Model Number: LXMC16
• Device Catalogue Number: LXMC16
• Device Lot Number: 23859
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/05/2019
• Initial Date FDA Received: 12/18/2019
• Supplement Dates Manufacturer Received: 12/19/2019; 01/13/2020
• Supplement Dates FDA Received: 01/10/2020; 02/06/2020
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 88