MAUDE Adverse Event Report: TORAX MEDICAL, INC. LS12; ANTI-REFLUX IMPLANT

Catalog Number LS12

Device Problem Material Erosion (1214)

Patient Problems Erosion (1750); Dysphagia/ Odynophagia (1815); Nausea (1970); Pain (1994); No Code Available (3191)

Event Date 08/28/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 09/23/2019.Additional information reported: what was the date of original linx implant? (b)(6) 2012.It was reported that on (b)(6) 2019 the attempt was made to explant the device.Please explain what complications were experienced that did not allow for the device to be removed? non eroded beads were embedded in the esophageal wall and could not be safely removed laparoscopically.What is the scheduled date for the secondary endoscopic explant? (b)(6) 2019.What was the sizing technique that was used (sizing of the esophagus instructions per the ifu or another technique) for original linx implant? standard sizing tool used in 2012.What were the first clinical symptoms that provided evidence of an erosion and when did they first occur? she came to dr.Humans office for follow up 10 days after getting food stuck that had caused her the inability to belch.She also had chest and back pain, neck and arm pain and nausea.She was concerned about herniation from heavy lifting done recently as well.Er visit on (b)(6) had ekg and ct done, both negative.Has the patient had any dilations, egd, or other procedure between the linx implant and discovery of the erosion? please describe and include the dates of the procedures.Egd/bravo was done one year post linx at (b)(6) on (b)(6) 2019.No issues and bravo was negative.She had and egd done by dr.(b)(6) about a year ago and she told me everything was fine.Are pictures or videos available? pictures are available from the egd.How many beads eroded? we could see 2 beads on the egd done at (b)(6) on (b)(6) 1954, no dilation or biopsies were done.This was done under fluro and they were not expecting erosion.Where were the eroded beads positioned? anterior surface of the esophageal mucosa.What is the current condition of the patient? stable.Update: images coming next week.

Event Description

It was reported that there was a linx erosion.We had the patient go to (b)(6), to see a physician.Physician tried yesterday ((b)(6) 2019) to remove the device and was unsuccessful.Patient is going to go back in three weeks, and they are going to try to do it (remove the linx device) endoscopically.The model number is ls12, lot number was 3457 and serial number (b)(4).

Manufacturer Narrative

(b)(4).Medical assessment of endoscopy photographs per ethicon, medical safety officer.I reviewed two endoscopic images which showed a retroflexed view of the gastroesophageal junction.The images are not very clear but, it appears that there is evidence of an eroded linx device at the cardia.Only one bead is visible in both images.The mechanism/cause of failure cannot be determined from the provided images.

Manufacturer Narrative

(b)(4).Date sent: 10/18/2019.The dhr of lot 3457 was reviewed.No ncs, reworks, or defects related to the product complaint were found.Additional information received: a second attempt to remove the eroded device was attempted (exact date unknown, (b)(6), 2019).The surgeon was able to remove two additional linx eroded beads.Another explant attempt (#3) will be scheduled.Egd images prior to attempts at explant, confirming erosion.Subject presented to ed with eroded linx device.Several days later she was taken to the or for attempted linx removal.At that time, the surgeon was only unable to uncover 4 linx beads.Given that the surgeon did not want to make any unnecessary enterotomies, and that the patient was stable, with gradually improving symptoms, and her linx seemed to be evolving and gradually eroding inward, they elected to stop, continue to treat her symptoms, and bring her back to the endoscopy suite with fluoroscopic abilities in several weeks once the linx was fully eroded, and remove at that time.After several weeks the patient was taken to endoscopy, and they were able to successfully remove two beads, with the rest of the beads remaining.The patient was seen in clinic a few weeks later, presenting with persistent nausea and mild dysphagia since that time.Given the objective workup and inability to remove endoscopically, the surgeon plans to proceed with laparoscopic transgastric removal of the linx device.

Manufacturer Narrative

(b)(4).Date sent: 11/12/2019.Additional information received: indications: patient is a 65 year old female who previously had a linx placed for gerd.The device eroded into the stomach.Previous attempts at endoscopic removal were only partially successful and 10 titanium beads still remained.Risks, benefits and alternatives to surgery were discussed in detail and written consent was obtained.Procedure note: the patient was taken to the operative room and placed on the operating room table in the supine position.Following the induction of general endotracheal anesthesia, preoperative antibiotics were administered and scds were placed to bilateral lower extremities.The abdomen was prepped and draped in the usual sterile fashion.A formal time-out was performed prior to the start of the procedure.A 5 mm infraumbilical incision was created using a scapel.A veress needle was inserted, and position confirmed in peritoneal cavity using saline drop test.The abdomen was insufflated with co2 pneumoperitoneum of 15mmhg.A 5mm trocar and the laparoscope were then introduced.An additional 5 mm port was placed in the left upper quadrant.An endoscope was used to inflate the stomach and visualize the linx device at the gej.Two additional left quadrant 5 mm ports were placed transgastrically.The device was freed from its attachments and then removed endoscopically with and endoscopic snare.We then upsized the 5 mm port to 12 mms.The two gastrotomies were closed with interrupted vicryl.We reintroduced the endoscope and performed a leak test.The leak test was negative.Satisfied with our operation, we closed the fascia of the 12 mm port with an 1 vicryl on a carter thompson.The remaining ports were removed under direct visualization.Skin was closed with 4-0 vicryl.All counts were correct x 2 at the completion of the case.The remaining 10-beads were removed (b)(6) 2019.

• Brand Name: LS12
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 9104019
• MDR Text Key: 162643722
• Report Number: 3008766073-2019-00471
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005011
• UDI-Public: 00855106005011
• Combination Product (y/n): N
• PMA/PMN Number: P100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/29/2019

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: 04/10/2016
• Device Catalogue Number: LS12
• Device Lot Number: 3457
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/29/2019
• Initial Date FDA Received: 09/23/2019
• Supplement Dates Manufacturer Received: 08/29/2019; 10/28/2019; 12/10/2019
• Supplement Dates FDA Received: 10/18/2019; 11/12/2019; 12/10/2019
• Patient Sequence Number: 1
• Patient Age: 65 YR