MAUDE Adverse Event Report: TORAX MEDICAL, INC. LINX 1.5 16 BEAD US; ANTI-REFLUX IMPLANT

Model Number LXMC16

Device Problems Device Appears to Trigger Rejection (1524); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Dysphagia/ Odynophagia (1815); Pain (1994); Vomiting (2144); Hernia (2240); Choking (2464); Abdominal Distention (2601)

Event Date 01/27/2022

Event Type  Injury  

Event Description

It was reported that the patient was unwilling to follow surgeon suggested treatment options and even unwilling to go for a dilation to resolve dysphasia.Patient stated and complained that she simply wants the linx removed.

Manufacturer Narrative

Pc-(b)(4).Lot number was received and dhr is pending review.When the review is completed, a supplemental medwatch will be sent with a summary of the evaluation.Additional information received: explant surgery was performed on thursday (b)(6) 2022 @ 7:30 am.Additional information was requested, and the following was obtained: prior to linx placement, did the patient have an egd, ph, and manometry studies done? if yes, could you please share the results? the patient had the standard workup prior to linx placement ¿ esophagram, and ph studies-test results indicated patient was a candidate for linx device.Before linx removal- dr.Bowersock ordered upper gi- which patient completed.He also ordered egd and the patient refused.What is the lot number of the linx device? 26215.When using the linx sizing device what technique was used to determine the size? how the white sizer looks on the esophagus, as well as popoff of3.Final determination based on how the sizer looks, not touching all the way, next click touching all the way around and before compression of the esophagus.Did the patient have an autoimmune disease? no.Is the patient currently taking steroids / immunosuppressive drugs? no.Did the patient have any pre-existing dysphagia or other conditions (other than gerd)? mild dysphagia.How severe was the dysphagia/odynophagia before intervention? mild.Were there any intra-operative complications during implant? no.Was there any hiatal or crural repair done at the same time as the implant? a small recurrent hh was repaired during this procedure & crural repair done during same procedure.Were there any other contributing factors that led to the removal of the device other than the reported dysphagia?patient c/ovomiting and epigastric abdominal pain/bloating with chokingwhen attempting to eat any solid foods.Besides the reported dysphagia, what was the reason for removal of the linx device? patient c/ovomiting and epigastric abdominal pain/bloating with choking and a small recurrent hiatal hernia.Was the device found in the correct position/geometry at the time of removal? yes.Please provide the status of the device(s) as it has not been received for analysis.Device was not saved, it was accidentally or simply disposed of after the case by the hospital.

Manufacturer Narrative

(b)(4).Date sent: 3/3/2022.Investigation summary: an analysis of the product could not be performed since a physical sample was not received for evaluation.As part of ethicon's quality process, all devices are manufactured, inspected, and distributed to approved specifications.If the product is received at a later date, the investigation will be updated as applicable.A manufacturing record evaluation was performed for the finished device batch number: 26215, and no non-conformances were identified.

• Brand Name: LINX 1.5 16 BEAD US
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• Manufacturer Contact: kara ditty-bovard ; 4188 lexington avenue north; shoreview 55126 ; 6107428552
• MDR Report Key: 13579767
• MDR Text Key: 287906473
• Report Number: 3008766073-2022-00037
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005363
• UDI-Public: 00855106005363
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/03/2022

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/15/2023
• Device Model Number: LXMC16
• Device Catalogue Number: LXMC16
• Device Lot Number: 26215
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/03/2022
• Initial Date FDA Received: 02/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female