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

Model Number	LXC15
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Heartburn/Indigestion (1883)
Date of Event	07/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Per (b)(6)hospital on 8/30/2018: the device will not be returned due to patient keeping the explanted device.
Event or Problem Description
Following a laparoscopic anti-reflux procedure, a patient experienced ongoing gerd and abdominal pain leading to explant of the linx device.The linx device was used as part of the anti-reflux procedure.Anti-reflux procedure including linx device implantation and repair of a "small sliding hiatal hernia", measuring 1-2 cm occurred without issue on (b)(6) 2015.The patient reported on 07/16/2015 that she began to experience mild dysphagia, which began (b)(6) 2015, and a barium swallow "exhibited laryngeal penetration seen with numerous swallows.This improved with chin tuck.No frank aspiration.Otherwise, unremarkable esophagram status post-linx procedure".This was resolved by (b)(6) 2016.The patient underwent mini gastric bypass procedure in (b)(6) in (b)(6) 2017 and lost 50 lbs since the procedure.An egd with ph testing occurred on (b)(6) 2017 where the patient reported reflux symptoms have improved, and she stopped taking omeprazole in (b)(6) 2017.The egd showed grade b esophagitis with "short linear ulcers; wide open" and a grade 1 valve.Pathologic analysis of ge junction biopsy showed mild chronic inflammation.Ph testing resulted in day 1 acid exposure of 10.1% (demeester score 27.2) and day 2 acid exposure of 5.1% (demeester score 17.1).The patient complained of very frequent belching, chest pain, and heartburn, with very likely symptom correlation.Upper gi endoscopy performed on (b)(6) 2017 showed no esophagitis but an irregular scj with a 2 cm hiatal hernia, 12 cm gastric pouch and 2 lumen jejunal anastomosis.Upper gi endoscopy on (b)(6) 2018 showed "patulous ge junction with linx pinch 1 cm below scj", "loop anastomosis, both limbs healthy; much bile staining in stomach, with gastritis".Egd with bravo placement occurred on (b)(6) 2018.The patient was experiencing regurgitation and some heartburn (initially she experienced relief from reflux symptoms).The patient also experienced dysphagia with meats.The egd found a 2 cm hiatal hernia above the linx device with grade b esophagitis, and small linear ulcers were observed.A grade 1 valve was noted.Pathologic analysis of biopsies of the stomach/atrium showed "patchy mild chronic inflammation".Wireless ph testing showed day 1 acid exposure of 5.1% (demeester score 19.4) and day 2 acid exposure of 0.1% (demeester score of 1.2).The patient complained of frequent heartburn, cough, and belching with low symptom correlation.Device explant due to ongoing gerd symptoms and abdominal pain occurred without issue on (b)(6) 2018 with dr.(b)(6).Additionally during explant, the surgeon revised the mini gastric bypass (one anastomosis) to a roux-en-y bypass (2 anastomosis) to resolve bile reflux, a repair of a hiatal hernia, and the removal of the linx device.

• 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: 7876228
• Report Number: 3008766073-2018-00148
• Device Sequence Number: 16656471
• Product Code: LEI
• UDI-Device Identifier: 00855106005165
• UDI-Public: 00855106005165
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P100049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/15/2018

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
• Operator of Device: No Information
• Device Expiration Date: 07/30/2018
• Device Model Number: LXC15
• Device Lot Number: 6542
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2018
• Initial Report FDA Received Date: 09/14/2018
• 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: 54 YR