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

Model Number LXMC17

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

Patient Problem Pneumothorax (2012)

Event Date 08/21/2018

Event Type  Injury  

Manufacturer Narrative

Device was not explanted and will not be returned.

Event Description

During a laparoscopic anti-reflux procedure, a patient developed a pneumothorax.The linx device was used as part of the anti-reflux procedure.-anti-reflux procedure implantation including hiatal hernia repair occurred on (b)(6) 2018 -during dissection, to create adequate esophageal length in the abdomen, the patient developed a pneumothorax.-a small incision was made in the diaphragm below the patient's left lung.A small incision was made externally just below the patient's left ribs.A small flexible tube was inserted through both small incisions and secured with suture in the diaphragm.This released the air between the lung and the chest wall, allowing the lung to re-inflate.Once the lung inflated, the tube was removed and the small incision created in the diaphragm sealed itself.The external incision was sutured closed.-dr.(b)(6) does not believe that this was a serious event as it was treated intra-operatively and did not require hospitalization.-the patient went home the same day and no-pneumothorax was found on the post-op chest x-ray.After the implant procedure and before discharge the following tests were performed: -abdominal chest x-rays (2 views) ((b)(6) 2018) - mild reflux was observed.It was observed that the "linx ring noted at the level of the ge junction.Left greater than right basal atelectasis, mild pneumonia at the left base not excluded with a small left plural effusion." -barium swallow ((b)(6) 2018) - the linx device was observed in "satisfactory" position and "some reflux noted and tertiary waves evident".There was also "no evidence for obstruction in the gastric sleeve" and no extravasation.-dr.(b)(6) reported that the patient was "doing well when we called on him last week" (on approximately (b)(6) 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
• Manufacturer (Section G): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN 55126
• Manufacturer Contact: steve nelson ; 4188 lexington avenue north; shoreview, MN 55126 ; 6513618900
• MDR Report Key: 7893283
• MDR Text Key: 120838770
• Report Number: 3008766073-2018-00150
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005370
• UDI-Public: 00855106005370
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/21/2018

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: No Information
• Device Expiration Date: 04/17/2022
• Device Model Number: LXMC17
• Device Lot Number: 19823
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/21/2018
• Initial Date FDA Received: 09/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2018
• 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: 59 YR