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

Model Number	LS15
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Heartburn/Indigestion (1883)
Date of Event	05/04/2018
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue n; shoreview MN 55126
• MDR Report Key: 7562488
• Report Number: 3008766073-2018-00095
• Device Sequence Number: 1754443
• Product Code: LEI
• UDI-Device Identifier: 00855106005042
• UDI-Public: 00855106005042
• 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: 2009
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Physician
• Device Expiration Date: 09/23/2009
• Device Model Number: LS15
• Device Lot Number: 1614
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2018
• Initial Report FDA Received Date: 06/01/2018
• 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; Other
• Patient Age: 54 YR