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); Appropriate Term/Code Not Available (3191); Patient Device Interaction Problem (4001)

Patient Problems Dysphagia/ Odynophagia (1815); Foreign Body In Patient (2687)

Event Date 09/26/2022

Event Type  Injury  

Event Description

It was reported via clinical trial patient (b)(6) experience, esophageal foreign body.Relationship to study device probable.

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: patient identifier: (b)(6).(b)(6).Sex: male.Age (at time of consent): 37 years.Model: lxmc16.Device lot number: 28805.Date of surgery: (b)(6) 2022.Adverse event term: esophageal foreign body.Severity: mild.Is the adverse event serious? yes.Relationship to study device: probable.Required in-patient hospitalization or prolongation of existing hospitalization: yes.Admission date: (b)(6) 2022.Diagnostic imaging: yes.Drug therapy: yes.Required in-patient hospitalization or prolongation of existing hospitalization : no.Yes.Is the adverse event serious? (if yes, check all that apply) : no.Yes.Discharge date : (b)(6) 2022.Outcome : not recovered/not resolved.Recovered/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: 12/12/2022.Additional information received: the event description states ¿esophageal foreign body¿.What was the esophageal foreign body? i believe it was a piece of chicken that the patient eventually swallowed on his own.Was it food? yes.Did the patient have issues swallowing? yes.Did a dilation take place? not in september.He was still having occasional symptoms and was dilated on (b)(6) 2022.If yes, what type of dilation and what was the date? dilation with an 18-19-20mm balloon dilator was performed to 20mm with a tts dilator.

Manufacturer Narrative

(b)(4).Date sent: 12/1/2022.Investigation summary: an analysis of the product could not be performed since a physical sample was not received for evaluation.A manufacturing record evaluation was performed for the finished device batch number 28805, and no non-conformances were identified.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.H6: a01 should be a27.

Manufacturer Narrative

(b)(4); date sent: 12/13/2022.Additional information received: indicate type of dilation? pneumatic.Diagnostic imaging: yes.

Manufacturer Narrative

(b)(4).Date sent: 3/29/2023.Additional information received: if event is serious and device related, according to the protocol and instructions for use, in the opinion of the investigator, is the adverse event expected/anticipated? : blank => n/a.If the event is marked as being related to the procedure, indicate which procedure the event is related to : blank => index indicate type of dilation? : blank => pneumatic relationship to study device : blank => probable awareness date : 12 dec 2022 => 18 oct 2022 relationship to study procedure : blank => possible.End date : blank => (b)(6) 2022 admission date: (b)(6) 2022.Discharge date: (b)(6) 2022.Dilation performed : yes => no.Outcome : unknown => recovered/resolved.Date of dilation: (b)(6) 2022.

Manufacturer Narrative

(b)(4).Additional information received; updated log line 2, outcome : unknown => not recovered/not resolved.

• 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: kate karberg ; 4188 lexington avenue north; shoreview ; 3035526892
• MDR Report Key: 15579603
• MDR Text Key: 306410481
• Report Number: 3008766073-2022-00201
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005363
• UDI-Public: 00855106005363
• 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: Study
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LXMC16
• Device Catalogue Number: LXMC16
• Device Lot Number: 28805
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/27/2022
• Initial Date FDA Received: 10/11/2022
• Supplement Dates Manufacturer Received: 12/01/2022; 12/12/2022; 12/13/2022; 03/16/2023; 11/29/2023
• Supplement Dates FDA Received: 12/01/2022; 12/12/2022; 12/13/2022; 03/29/2023; 12/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Patient Sex: Male