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

Model Number LS12

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

Patient Problems Erosion (1750); Dysphagia/ Odynophagia (1815)

Event Date 12/01/2016

Event Type  Injury  

Event Description

Following a laparoscopic anti-reflux procedure, a patient experienced epigastric pain leading to endoscopic visualization of two device beads eroded into the esophageal lumen and subsequent endoscopic explant of the eroded linx device beads.The linx device was used as part of the anti-reflux procedure.-anti-reflux procedure and linx device implantation occurred without issue (b)(6) 2014.-two device beads were observed endoscopically on (b)(6) 2016 in the left side of the esophageal lumen.The physician believes that the cause of the erosion may have been a stuck pill of ibuprofen at the level of the device which may have then created an ulcer; the physician did not provide any direct evidence to support this hypothesis however.-the two beads were removed endoscopically with a loop-cutter on (b)(6) 2016; the remaining beads are planned to be removed laparoscopically in 2-3 months.

Event Description

Following a laparoscopic anti-reflux procedure, a patient experienced epigastric pain leading to endoscopic visualization of two device beads eroded into the esophageal lumen and subsequent endoscopic explant of the eroded linx device beads.The linx device was used as part of the anti-reflux procedure.Anti-reflux procedure and linx device implantation occurred without issue (b)(6) 2014.Two device beads were observed endoscopically on (b)(6) 2016 in the left side of the esophageal lumen.The physician believes that the cause of the erosion may have been a stuck pill of ibuprofen at the level of the device which may have then created an ulcer; the physician did not provide any direct evidence to support this hypothesis however.The two beads were removed endoscopically with a loop-cutter on (b)(6) 2016.The patient is reported as doing great after removal without any reflux.There are no plans between the physician and patient to remove the remaining beads of the device at this time.

Event Description

Following a laparoscopic anti-reflux procedure, a patient experienced epigastric pain leading to endoscopic visualization of two device beads eroded into the esophageal lumen and subsequent endoscopic explant of the eroded linx device beads.The linx device was used as part of the anti-reflux procedure.Anti-reflux procedure and linx device implantation occurred without issue (b)(6) 2014.Two device beads were observed endoscopically on (b)(6) 2016 in the left side of the esophageal lumen.The physician believes that the cause of the erosion may have been a stuck pill of ibuprofen at the level of the device which may have then created an ulcer; the physician did not provide any direct evidence to support this hypothesis however.The two beads were removed endoscopically with a loop-cutter on (b)(6) 2016.The patient is reported as doing great after removal without any reflux.There were no plans as of (b)(6) 2017 between the physician and patient to remove the remaining beads of the device.The patient experienced dysphagia and was treated via 18mm pneumatic balloon dilation in (b)(6) 2017.The patient returned with intermittent dysphagia and was scoped on (b)(6) 2017 showing one bead in the lumen of the esophagus.The remaining 10 beads were removed endoscopically on (b)(6) 2017.

Event Description

Following a laparoscopic anti-reflux procedure, a patient experienced epigastric pain leading to endoscopic visualization of two device beads eroded into the esophageal lumen and subsequent endoscopic explant of the eroded linx device beads.The linx device was used as part of the anti-reflux procedure.Anti-reflux procedure and linx device implantation occurred without issue (b)(6) 2014.Two device beads were observed endoscopically on (b)(6) 2016 in the left side of the esophageal lumen.The physician believes that the cause of the erosion may have been a stuck pill of ibuprofen at the level of the device which may have then created an ulcer; the physician did not provide any direct evidence to support this hypothesis however.The two beads were removed endoscopically with a loop-cutter on (b)(6) 2016.The patient is reported as doing great after removal without any reflux.There were no plans as of (b)(6) 2017 between the physician and patient to remove the remaining beads of the device.The patient experienced dysphagia and was treated via 18mm pneumatic balloon dilation in (b)(6) 2017.The patient returned with intermittent dysphagia and was scoped on (b)(6) 2017 showing one bead in the lumen of the esophagus.The remaining 10 beads were removed endoscopically on (b)(6) 2017.

• Brand Name: LINX REFLUX MANAGEMENT SYSTEM
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue n; shoreview MN 55126
• Manufacturer (Section G): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN 55126
• Manufacturer Contact: daniel hoseck ; 4188 lexington avenue north; shoreview, MN 55126 ; 6513618900
• MDR Report Key: 6209316
• MDR Text Key: 63410936
• Report Number: 3008766073-2016-00111
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005011
• UDI-Public: 00855106005011
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/14/2017

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: 10/23/2016
• Device Model Number: LS12
• Device Lot Number: 4070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/01/2016
• Initial Date FDA Received: 12/28/2016
• Supplement Dates Manufacturer Received: Not provided; 09/14/2017; 09/14/2017
• Supplement Dates FDA Received: 01/27/2017; 10/10/2017; 10/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/23/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability
• Patient Age: 68 YR
• Patient Weight: 69