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

Model Number LXM15

Device Problem Defective Component (2292)

Patient Problem Pyrosis/Heartburn (1883)

Event Date 03/05/2018

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 linx device implantation occurred without issue on an unknown date.Patient experienced reflux for about 2 months prior to discovery of the separated device.X-ray during the first week of (b)(6) 2018 visualized the discontinuous device.X-ray showed the device separated between two beads with an exposed wire and weld ball visible.Device explant due to the device opening occurred without issue on (b)(6) 2018.

Manufacturer Narrative

Updated description of event or problem to include implant date and patient status.Updated test/laboratory data to include device analysis.Updated implant date to include implant date.Updated adverse event problem to include method codes 10, 84, 3354, 3371, and 3336.Updated report date.

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 linx device implantation occurred without issue in (b)(6) 2017.Patient experienced reflux for about 2 months prior to discovery of the separated device.X-ray during the first week of 03/2018 visualized the discontinuous device.X-ray showed the device separated between two beads with an exposed wire and weld ball visible.Device explant due to the device opening occurred without issue on (b)(6) 2018.Physician reported that a second weld ball pulled through a washer during the explant procedure.The patient is doing well as of (b)(6) 2018, and a replacement linx implant is planned for (b)(6) 2018.

Manufacturer Narrative

Corrected device analysis in relevant tests/laboratory data to include results for two sets of bead separations.Updated report date.

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 linx device implantation occurred without issue in 03/2017.Patient experienced reflux for about 2 months prior to discovery of the separated device.X-ray during the first week of 03/2018 visualized the discontinuous device.X-ray showed the device separated between two beads with an exposed wire and weld ball visible.Device explant due to the device opening occurred without issue on (b)(6) 2018.Physician reported that a second weld ball pulled through a washer during the explant procedure.The patient is doing well as of on (b)(6) 2018, and a replacement linx implant is planned for 08/2018.

• 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
• MDR Report Key: 7421475
• MDR Text Key: 105147540
• Report Number: 3008766073-2018-00059
• Device Sequence Number: 1
• Product Code: LEI
• Combination Product (y/n): N
• PMA/PMN Number: P100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/18/2018

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: 09/12/2020
• Device Model Number: LXM15
• Device Lot Number: 12058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/12/2018
• Initial Date FDA Received: 04/11/2018
• Supplement Dates Manufacturer Received: 04/17/2018; 05/18/2018
• Supplement Dates FDA Received: 05/14/2018; 06/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 56 YR