MAUDE Adverse Event Report: TORAX MEDICAL, INC. 1.5T LINX, 15B; ANTI-REFLUX IMPLANT

Model Number LXMC15

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

Patient Problems Diarrhea (1811); Dysphagia/ Odynophagia (1815); Pyrosis/Heartburn (1883); Inflammation (1932); Paresis (1998); Vomiting (2144); Hernia (2240)

Event Date 03/21/2023

Event Type  Injury  

Event Description

It was reported that a linx was implanted on (b)(6) 2018 and explanted on (b)(6) 2023 for reasons unknown.No more information is available.

Manufacturer Narrative

(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: this patient in particular had dysphagia even post dilation although she also had a post-op elevated demeester score.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? yes, egd on (b)(6) 2018.Impressions: mild gastritis, esophagitis, hiatal hernia.Pathology: gastroesophageal junction: gastric mucosa with moderate inactive chronic gastritis; attached benign squamous mucosa.Gastric antrum: antral mucosa with moderate inactive chronic gastritis.A steiner stain reveals very rare organisms suggestive of helicobacter.When using the linx sizing device what technique was used to determine the size? the measurement was done with the length measuring devise sizer.(there was a proctor present for this implant.) 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)? no.How severe was the dysphagia/odynophagia before intervention? patient had egd/dilation on (b)(6) 2019, then again with bravo on 03/31/2021-demeester score was 38.4.Patient described the need to vomit at the initial bite of food and then would be able to eat-1/20/203.Diagnosed with gastroparesis in (b)(6) 2019.Diarrhea within 30 minutes of eating of drinking.Were there any intra-operative complications during implant? no.Was there any hiatal or crural repair done at the same time as the implant? yes.Were there any other contributing factors that led to the removal of the device other than the reported dysphagia? recurrent reflux- demeester of 38.4 post linx.Besides the reported dysphagia, what was the reason for removal of the linx device? see above.Was the device found in the correct position/geometry at the time of removal? yes.Post-op removal, the patient has minimal reflux- recognizes foods to avoid reflux and the chronic diarrhea and dysphagia (unless she eats too fast) have resolved.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

(b)(4).Date sent: 6/8/2023.Investigation summary: an analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.However, 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 lot number: 21746, and no related nonconformances were identified.

• Brand Name: 1.5T LINX, 15B
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4545 creek road; cincinnati OH
• Manufacturer Contact: kate karberg ; 4188 lexington avenue north; shoreview ; 3035526892
• MDR Report Key: 16885310
• MDR Text Key: 314722361
• Report Number: 3008766073-2023-00079
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005356
• UDI-Public: 00855106005356
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 06/08/2023

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: 06/25/2022
• Device Model Number: LXMC15
• Device Catalogue Number: LXMC15
• Device Lot Number: 21746
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/25/2023
• Initial Date FDA Received: 05/08/2023
• Supplement Dates Manufacturer Received: 06/08/2023
• Supplement Dates FDA Received: 06/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention