MAUDE Adverse Event Report: TORAX MEDICAL, INC. LXC14; ANTI-REFLUX IMPLANT

Catalog Number LXC14

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

Patient Problems Dysphagia/ Odynophagia (1815); High Blood Pressure/ Hypertension (1908); Pain (1994); No Code Available (3191)

Event Date 09/28/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch # unk.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date, a supplemental medwatch will be sent.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date, a supplemental medwatch will be sent.Did the patient have an autoimmune disease? is the patient currently taking steroids / immunization drugs? did the patient have any pre-existing dysphagia or other conditions (other than gerd)? how severe was the dysphagia/odynophagia before intervention? did the dysphagia improve after the device was implanted initially? were there any intra-operative complications during implant? was there any hiatal or crural repair done at the same time as the implant? what was the reason for removal of the linx device? was the device found in the correct position/geometry at the time of removal?.

Event Description

It was reported that post implant of lxc-14, lot number 7952, serial number (b)(4), device implanted (b)(6) 2014.On (b)(6) 2017: esophagram notes some intermittent tertiary peristaltic waves and a little bit of delay in emptying.On (b)(6) 2017: patient has been experiencing troublesome swallowing and increased pain to upper abdomen which developed approx.1 year ago.On (b)(6) 2017: 36-month questions indicate dysphagia as ongoing.On (b)(6) 2017: symptoms continue plan is to monitor.On (b)(6) 2018: based on continued hb, regurgitation, worsening pain and dysphagia a decision was made to explant.Procedure conducted successful and no additional procedure needed at this time.Dysphagia improved the following morning with breakfast per patient.The patient did stay two nights after the explant ((b)(6) 2018) due to nausea.The patient was discharged on (b)(6) 2018.It is unknown if the device is available for return.(b)(6).

Manufacturer Narrative

(b)(4).Dilation was done on (b)(6) 2018.This information was omitted on the initial report.

Manufacturer Narrative

(b)(4).Additional information: the dhr for lot 8257 was reviewed.Note: based on manufacturing records, the lot number of this device is 5287 and the serial number is (b)(4) (in the event description it was reported that the lot number was 7952 and the serial number was (b)(4) , no such device exists).Model number is lxc14.No non-conformances, defects, or reworks were found related to the device complaint.

Manufacturer Narrative

(b)(4).Device analysis: overall review of the device function and dimensions show no anomalies from a device that has been reasonably changed as part of the explant procedure.Visual analysis was consistent with an explanted device, and link length and tensile force were found to meet the applicable specifications.Overall, no analysis conclusions relevant to the patient experience were found.

• Brand Name: LXC14
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 7985697
• MDR Text Key: 124490840
• Report Number: 3008766073-2018-00194
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005349
• UDI-Public: 00855106005349
• Combination Product (y/n): N
• PMA/PMN Number: P100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/04/2018

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: Health Professional
• Device Expiration Date: 09/26/2017
• Device Catalogue Number: LXC14
• Device Lot Number: 7952
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2019
• Initial Date Manufacturer Received: 10/04/2018
• Initial Date FDA Received: 10/19/2018
• Supplement Dates Manufacturer Received: 10/17/2018; 11/19/2018; 01/14/2019
• Supplement Dates FDA Received: 11/07/2018; 11/19/2018; 02/05/2019
• Patient Sequence Number: 1
• Patient Age: 73 YR