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

Model Number	LX12
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Erosion (1750)
Date of Event	09/27/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Following a laparoscopic anti-reflux procedure, a patient experienced abdominal pain to endoscopic visualization of linx device beads within the esophageal lumen on (b)(6) 2016.The linx device was used as part of the anti-reflux procedure.Anti-reflux procedure and linx device implantation occurred without issue on (b)(6) 2012 by dr.(b)(6).A hiatal hernia was repaired as part of the anti-reflux procedure.Patient reported difficulties swallowing/dysphagia after device implant.Esophagogastroduodenoscopy (egd) performed on (b)(6) 2016 showed linx device beads within the esophageal lumen.Uneventful endoscopic explant of single linx bead on (b)(6) 2016 by dr.(b)(6) at (b)(6).Physician plans to laparoscopically remove the remainder of the linx device in 3-4 months.
Additional Manufacturer Narrative
-update regarding removal of remainder of beads from 3-4 months to (b)(6) 2017.-device evaluation performed on single explanted bead.Device analysis conducted by torax medical engineering after product receipt.Gross analysis revealed no device anomalies atypical from an explanted device.Microscopic analysis revealed all device components and assembly exhibited normal characteristics of an explanted device.No conclusion relevant to experience determined.
Event or Problem Description
Following a laparoscopic anti-reflux procedure a patient experienced abdominal pain to endoscopic visualization of linx device beads within the esophageal lumen on (b)(6) 2016.The linx device was used as part of the anti-reflux procedure.-anti-reflux procedure and linx device implantation occurred without issue on (b)(6) 2012 by dr.(b)(6).-a hiatal hernia was repaired as part of the anti-reflux procedure.-patient reported difficulties swallowing/dysphagia after device implant.-esophagogastroduodenoscopy (egd) performed on (b)(6) 2016 showed linx device beads within the esophageal lumen.-uneventful endoscopic explant of single linx bead on (b)(6) 2016 by dr.(b)(6) at (b)(6).-physician plans to laparoscopically remove the remainder of the linx device in (b)(6) 2017.Patient reported as doing well.
Additional Manufacturer Narrative
-update regarding removal of remainder of beads from 3-4 months to (b)(6) 2017.-device evaluation performed on single explanted bead.Device analysis conducted by torax medical engineering after product receipt.Gross analysis revealed no device anomalies atypical from an explanted device.Microscopic analysis revealed all device components and assembly exhibited normal characteristics of an explanted device.No conclusion relevant to experience determined.Esophageal dilation (b)(6) 2015, remaining device removal (b)(6) 2017, and patient status after removal.Partial device return.
Event or Problem Description
Following a laparoscopic anti-reflux procedure a patient experienced abdominal pain leading to endoscopic visualization of linx device beads within the esophageal lumen on 09/27/2016 resulting in device explant.The linx device was used as part of the anti-reflux procedure.-anti-reflux procedure and linx device implantation occurred without issue on (b)(6) 2012 by dr.(b)(6).-a hiatal hernia was repaired as part of the anti-reflux procedure.-patient reported difficulties swallowing/dysphagia after device implant.-patient had an esophageal dilation on (b)(6) 2015 with no resolution.-esophagogastroduodenoscopy (egd) performed on (b)(6) 2016 showed linx device beads within the esophageal lumen.-uneventful endoscopic explant of single linx bead on (b)(6) 2016 by dr.(b)(6) at (b)(6).-uneventful laparoscopic explant of the remaining 11 linx device beads on (b)(6) 2017.-patient was reported as doing well and had no complaints after removal surgery.

• 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: 6048972
• Report Number: 3008766073-2016-00075
• Device Sequence Number: 360102
• Product Code: LEI
• UDI-Device Identifier: 00855106005035
• UDI-Public: 00855106005035
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P100049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/03/2017

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: 08/19/2014
• Device Model Number: LX12
• Device Lot Number: 2451
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/29/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 10/21/2016
• Supplement Report FDA Received Date: 11/21/2016; 03/13/2017
• 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: 47 YR
• Patient Weight: 60