MAUDE Adverse Event Report: TORAX MEDICAL, INC. LINX REFLUX MANAGEMENT SYSTEM; ANTI-REFLUX IMPLANT

Model Number LXMC16

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Sepsis (2067); Perforation of Esophagus (2399)

Event Date 07/22/2017

Event Type  Injury  

Event Description

Following a laparoscopic anti-reflux procedure, a patient was hospitalized due to surgical leak resulting in explant of the linx device.The linx device was used as part of the anti-reflux procedure.-anti-reflux procedure including hernia repair and linx device implantation occurred on (b)(6) 2017.-during hernia repair, it was noted that the hernia was larger than expected and a large amount of tissue dissection was required.-the posterior vagus nerve was cut during the implant procedure.-the device was well tolerated on (b)(6) 2017.-patient was septic and admitted to the hospital on (b)(6) 2017.-computer tomography angiography (cta) on (b)(6) 2017 showed an esophageal perforation.-device explant on (b)(6) 2017 when the patient was "finally healthy enough" to have device removed.-during explant, the device was below the ge junction due to either less than ideal placement or movement.

Event Description

Following a laparoscopic anti-reflux procedure, a patient was hospitalized due to surgical leak resulting in explant of the linx device.The linx device was used as part of the anti-reflux procedure.Anti-reflux procedure including a robotic paraesophageal hiatal hernia repair with biological mesh and linx device implantation occurred on (b)(6) 2017.During hernia repair, it was noted that the hernia was larger than expected and a large amount of tissue dissection was required.The posterior vagus nerve was "inadvertently" cut during the implant procedure.The patient remained in the hospital to recover from the hernia repair and implant.The device was well tolerated on (b)(6) 2017.Patient was septic and a surgical leak was discovered on (b)(6) 2017.The leak was into the left chest, no the mediastinum.Computer tomography angiography (cta) on (b)(6) 2017 showed an esophageal perforation.Patient underwent surgery including a left thoracotomy and a drainage procedure.The patient was medically paralyzed for 1 month after implant.The patient's stomach re-herniated.The physician believes this was due to coughing or retching in the first few days after the hernia repair was performed, which "undid" or "ripped" the repair.A barium swallow showed that the linx device "slipped onto the stomach", "was in the wrong place", and "was expanded." the physician believes the reason for the device's position was "it did not have the anchor of the posterior vagus nerve." device explant on (b)(6) 2017 when the patient was "finally healthy enough" to have device removed.Patient is "doing much better" as of (b)(6) 2017.

Event Description

Following a laparoscopic anti-reflux procedure, a patient was hospitalized due to surgical leak resulting in explant of the linx device.The linx device was used as part of the anti-reflux procedure.-anti-reflux procedure including a robotic paraesophageal hiatal hernia repair with biological mesh and linx device implantation occurred on (b)(6) 2017 -during hernia repair, it was noted that the hernia was larger than expected and a large amount of tissue dissection was required.-the posterior vagus nerve was "inadvertently" cut during the implant procedure.-the patient remained in the hospital to recover from the hernia repair and implant.-the device was well tolerated on (b)(6) 2017.-patient was septic and a surgical leak was discovered on (b)(6) 2017.The leak was into the left chest, no the mediastinum.-computer tomography angiography (cta) on (b)(6) 2017 showed an esophageal perforation.-patient underwent surgery including a left thoracotomy and a drainage procedure.-the patient was medically paralyzed for 1 month after implant.-the patient's stomach re-herniated.The physician believes this was due to coughing or retching in the first few days after the hernia repair was performed, which "undid" or "ripped" the repair.-a barium swallow showed that the linx device "slipped onto the stomach", "was in the wrong place", and "was expanded." the physician believes the reason for the device's position was "it did not have the anchor of the posterior vagus nerve." -device explant on (b)(6) 2017 when the patient was "finally healthy enough" to have device removed.-patient is "doing much better" as of (b)(6) 2017.

Manufacturer Narrative

-updated to include device information.-updated to include device manufacture date.-updated to include manufacturing review method code.-updated report date.

• Brand Name: LINX REFLUX MANAGEMENT SYSTEM
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN 55126
• MDR Report Key: 6999324
• MDR Text Key: 90969074
• Report Number: 3008766073-2017-00130
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/03/2018

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: Physician
• Device Expiration Date: 03/31/2021
• Device Model Number: LXMC16
• Device Lot Number: 14418
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2017
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/06/2017
• Initial Date FDA Received: 11/03/2017
• Supplement Dates Manufacturer Received: 12/01/2017; 01/03/2018
• Supplement Dates FDA Received: 12/27/2017; 01/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability
• Patient Age: 69 YR