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

Model Number LX15

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

Patient Problem Regurgitation (2259)

Event Date 12/03/2014

Event Type  Injury  

Event Description

Following a laparoscopic anti-reflux procedure, a patient experienced ongoing regurgitation leading to explantation of the linx device.The linx device was used as part of the anti-reflux procedure.Patient reported as experiencing ongoing regurgitation after anti-reflux procedure.Barium esophagram determined paraesophageal hernia (5cm x 5cm) was present post anti-reflux procedure.Explant procedure occurred on (b)(6) 2014.Physician removed only one bead of the linx device due to finding a fibrous capsule.Remaining device remains implanted.Nissen fundoplication performed simultaneous to explant procedure.Patient condition reported as well.

Manufacturer Narrative

Data received 08/27/2015 by manufacturer with successive device evaluation 09/18/2015: lot number 6267.Serial number (b)(4).Approximately june 30, 2015, remaining linx device was explanted.Device was explanted simultaneous to patient's fundoplication being undone due to herniation of the fundoplication.Device was found in the correct position and geometry.A second fundoplication was completed after undoing the initial fundoplication and removal of the remaining linx device.Patient is reported as well.09/18/2015: 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.Force testing, length testing, and geometric analysis exhibited no anomalies.No conclusion relevant to experience determined.

Event Description

Following a laparoscopic anti-reflux procedure, a patient experienced ongoing regurgitation leading to explantation of the linx device.The linx device was used as part of the anti-reflux procedure.Patient reported as experiencing ongoing regurgitation after anti-reflux procedure.Barium esophagram determined paraesophageal hernia (5 cm x 5 cm) was present post anti-reflux procedure.Explant procedure occurred (b)(6) 2014.Physician removed only one bead of the linx device due to finding a fibrous capsule.Remaining device remains implanted.Nissen fundoplication performed simultaneous to explant procedure.Patient condition reported as well.

• 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 n; shoreview MN 55126
• Manufacturer Contact: kevin klitz ; 4188 lexington avenue n; shoreview, MN 55126-0000 ; 6513618900
• MDR Report Key: 4381144
• MDR Text Key: 5240582
• Report Number: 3008766073-2014-00041
• Device Sequence Number: 1
• Product Code: LEI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: 100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/27/2015

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: 06/04/2018
• Device Model Number: LX15
• Device Lot Number: 9912
• Other Device ID Number: 00855106005103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2014
• Initial Date FDA Received: 12/31/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/04/2014
• 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: 61 YR