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

Model Number	LS12
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Dysphagia/ Odynophagia (1815)
Date of Event	12/01/2016
Type of Reportable Event	Serious Injury
Event or Problem 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 or Problem 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 or Problem 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 or Problem 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
• Common Device Name: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue n; shoreview MN 55126
• MDR Report Key: 6209316
• Report Number: 3008766073-2016-00111
• Device Sequence Number: 440116
• Product Code: LEI
• UDI-Device Identifier: 00855106005011
• UDI-Public: 00855106005011
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: P100049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2016
• Supplement Date Received by Manufacturer: Not provided; 09/14/2017; 09/14/2017
• Initial Report FDA Received Date: 12/28/2016
• Supplement Report FDA Received Date: 01/27/2017; 10/10/2017; 10/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Disability
• Patient Age: 68 YR
• Patient Weight: 69