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

Model Number LS15

Device Problem Malposition of Device (2616)

Patient Problem Pyrosis/Heartburn (1883)

Event Date 05/04/2018

Event Type  Injury  

Event Description

Following a laparoscopic anti-reflux procedure, a patient experienced ongoing gerd symptoms that lead to x-ray visualization of the linx device open.This led to explant of the linx device.The linx device was used as part of the anti-reflux procedure.Anti-reflux procedure including an interoperative endoscopy and linx device implantation occurred without issue on (b)(6) 2009.A biopsy was performed at the time showing peritoneal mesothelioma.Patient's ongoing gerd symptoms began in (b)(6) 2014.X-ray on (b)(6) 2017 lead to the initial visualization of the discontinuous device.X-ray showed that the device was intact; however, bead-to-bead separation was larger than normal.Further review of previous x-rays, show that the discontinuation occurred between (b)(6) 2013 and (b)(6) 2014.Device explant due to the device opening occurred without issue on (b)(6) 2018.A replacement linx was implanted at the time (model: lxmc16, lot#: 17685).It was noted that "both tie knots with suture (stretched between) were present - not discontinuous per se" and that the "sutures were still intact with both tie knots on the ends of the device were separated by more space than expected.So, on the x-ray it appears separate, discontinuous when in actuality it was not.It's as though the suture has slipped within the tie knot.".

• 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: tressa lauer ; 4188 lexington avenue north; shoreview, MN 55126 ; 6513618900
• MDR Report Key: 7562488
• MDR Text Key: 109836836
• Report Number: 3008766073-2018-00095
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005042
• UDI-Public: 00855106005042
• 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
• Report Date: 05/04/2018

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
• Device Operator: Physician
• Device Expiration Date: 09/23/2009
• Device Model Number: LS15
• Device Lot Number: 1614
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/04/2018
• Initial Date FDA Received: 06/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2009
• 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; Other
• Patient Age: 54 YR