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

Catalog Number LXM14

Device Problems Migration or Expulsion of Device (1395); Device Appears to Trigger Rejection (1524); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dysphagia/ Odynophagia (1815); Pain (1994)

Event Date 03/10/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).As the device was not returned, an analysis investigation could not be performed.A conclusion could not be reached as to what may have caused or contributed to the event.The dhr for lot 3110 was reviewed.No ncs, defects, or reworks related to the product complaint were found.Linx images were received and are pending review.When the review is completed, a supplemental medwatch will be sent with a summary of the evaluation.Additional information was requested, and the following was obtained: besides severe pain and difficulty swallowing were there any other clinical symptoms that provided evidence of erosion and when did they first occur? no other clinical symptoms, the erosion was discovered during an endoscopic procedure as the patient has pain.Has the patient had any dilations, egd, or other procedures between the linx implant and the discovery of the erosion? please describe and include the dates of the procedures.A barium swallow was completed -directly after the implantation.An endoscope was completed.-during the explantation.Was the patient stented? no.What is the current condition of the patient? good.

Event Description

It was reported that an lxm14, lot 3110 was implanted on (b)(6) 2012, due to reflux, small hernia with dosal hirodomiplasty.By the end of 2020, the patient was symptom-free.At the beginning of 2021, the patient complained of severe pain and difficulty swallowing.An endoscopy was performed at the end of (b)(6) 2021.Result: inward linx migration with 5 pearls.The implant was removed laparoscopically on (b)(6) 2021.The patient received a fundoplication.

Manufacturer Narrative

(b)(4).Date sent: 4/27/2021.Photo was provided for review by ethicon medical safety officer.Following are their observations: i reviewed 3 intraoperative photos, one still image from a barium swallow and one still image from an endoscopy associated with this complaint.The intraoperative photos showed creation of the posterior window between the vagus nerve and esophagus, sizing of the esophagus with the linx sizing device and placement of a linx clasp device around the esophagus.The barium swallow image showed contrast flowing through the esophagus with the linx device around the gej.The endoscopic image showed a retroflexed view of the cardia with what appears to be erosion of three beads into the stomach lumen.Final assessment erosion of the linx device.".

• Brand Name: LINX 1.5T 14 BEAD OUS
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 11614923
• MDR Text Key: 260514987
• Report Number: 3008766073-2021-00064
• Device Sequence Number: 1
• Product Code: LEI
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 03/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2015
• Device Catalogue Number: LXM14
• Device Lot Number: 3110
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR