MAUDE Adverse Event Report: TORAX MEDICAL, INC. 1.5T LINX, 13B; ANTI-REFLUX IMPLANT

Model Number LXMC13

Device Problems Device Appears to Trigger Rejection (1524); Patient Device Interaction Problem (4001)

Patient Problem Dysphagia/ Odynophagia (1815)

Event Date 12/06/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.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 was obtained: trx_2018_01: (b)(6), university of (b)(6), sex: male, age (at time of consent): (b)(6), model: lxmc13, device lot number: 26159, date of surgery: (b)(6) 2021, adverse event term: removal of linx device related to persistent dysphagia and excessive magnetic response between beads of linx device.Severity: severe.Is the adverse event serious? yes.Required in-patient hospitalization or prolongation of existing.Hospitalization: yes.Admission date: (b)(6) 2021.Discharge date: (b)(6) 2021, relationship to study device: probable.Intervention/treatment: none: yes, dilation performed: yes, indicate type of dilation? mechanical, date of dilation: (b)(6) 2021, diagnostic intervention: yes, diagnostic imaging: yes, drug therapy: yes, observation: yes, linx explant: yes, outcome: recovered/resolved.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? no.Yes, additional information was requested, and the following was obtained: what was the date of the explant? (b)(6) 2021.What does ¿excessive magnetic response between beads¿ mean? during an endoflip procedure performed, there was a pressure observed that would not release at the region of the linx device, consistent with the patient's dysphagia symptoms.What affect did the ¿¿excessive magnetic response between beads¿ have on the patient? despite dilation the patient experienced prolonged and severe dysphagia.The patient has been unable to tolerate solid foods, essentially since his initial post-surgical follow-up visit.How was the ¿¿excessive magnetic response between beads¿ determined? while it is only a determination based on observation via endoflip procedure, it appeared that the cause of the patient's dysphagia symptoms was a result of pressure presumably from the linx device.It appeared that the magnetic force between each bead would not release, hence constant pressure observed during endoflip if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported via clinical trial patient experienced removal of linx device related to persistent dysphagia and excessive magnetic response between beads of linx device.Relationship to study device: probable.

Manufacturer Narrative

(b)(4).Date sent: 1/27/2022.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 26159, and no non-conformances were identified.

Manufacturer Narrative

(b)(4).Date sent: 2/1/2022.Additional information received: from my notes it appears that the subject was dilated during their admission from on (b)(6) 2021 then the explant occurred during the admission from on (b)(6) 2021.Per source, on (b)(6), patient underwent diagnostic laparoscopy, removal of intra-abdominal foreign body, esophagogastroduodenoscopy with dilation.Dense adhesions around the lynx beads.Lynx beads removed.

Manufacturer Narrative

(b)(4).Date sent: 3/24/2022.Additional information received: (b)(6) log line: 4 adverse event term: right arm pain at former iv site, relationship to study device: not related, relationship to primary study procedure: not related.Adverse event for (b)(6) log line: 1 resulted in medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function : no : yes.Relationship to study device : probable : causal relationship.Adverse event for (b)(6) log line: 5, indicate type of dilation? pneumatic, date of dilation: (b)(6) 2021.Adverse event for (b)(6) log line: 3 adverse event term: pain with swallowing food, relationship to study device: possible, relationship to primary study procedure: unlikely, drug therapy: yes.

Manufacturer Narrative

(b)(4).Date sent: 5/6/2022.Additional information provided: required in-patient hospitalization or prolongation of existing hospitalization: yes.Admission date: on (b)(6) 2021.Discharge date: on (b)(6) 2021.Relationship to study device: possible.Relationship to primary study procedure: not related.Diagnostic imaging: yes.Drug therapy: yes.Observation: yes.Laparoscopic procedure removal: yes.Adverse event term: right arm pain at former iv site.Relationship to study device: not related.Relationship to primary study procedure: not related.

Manufacturer Narrative

(b)(4).Date sent; 6/8/2022.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? : n/a, yes.

Manufacturer Narrative

(b)(4).Date sent: 6/20/2022.Additional information received: what does ¿excessive magnetic response between beads¿ mean? immediately after the implant on postop day 0 of the night of surgery and postop day 1 the patient experienced severe dysphagia to solid food.In my experience this is exceedingly abnormal as usually we do not develop deficits dysphagia in total 10 to 14 days postoperatively.Her imaging revealed that the beads were in the correct position.1 hypothesis is that the were or if magnets that were used to manufacture this particular linx implant were higher than normal magnetic field and therefore created the dysphagia.How was the ¿¿excessive magnetic response between beads¿ determined? excessive magnetic response between beads was not determined.It was hypothesized as 1 possible etiology of the severe dysphagia that occurred immediately postop.To determine whether or not there was excessive magnetic force between the beads i have explant of the lynx implant and sent a pack to ethicon for evaluation to see if there is excessive magnetic force beyond the manufacturer specifications.Additional comments from medical safety officer: while it can be mentioned in the narrative as such, the surgeon¿s ¿hypothesis¿ should not be considered a pec or ac.It¿s just a guess.

Manufacturer Narrative

(b)(4); date sent: 8/11/2022.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? : yes -n/a.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 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? : yes -blank.

Manufacturer Narrative

(b)(4).Date sent: 10/12/2023 additional information provided: if yes, choose the primary ae log line, start date and term: : #002 (b)(6) 2021-dysphagia => #001 (b)(6) 2021-dysphagia.

• Brand Name: 1.5T LINX, 13B
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4545 creek road; cincinnati OH
• Manufacturer Contact: kara ditty-bovard ; 4188 lexington avenue north; shoreview 55126 ; 6107428552
• MDR Report Key: 13078165
• MDR Text Key: 287417764
• Report Number: 3008766073-2021-00266
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005332
• UDI-Public: 00855106005332
• Combination Product (y/n): N
• 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: 10/12/2023

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: 09/27/2023
• Device Model Number: LXMC13
• Device Catalogue Number: LXMC13
• Device Lot Number: 26159
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/09/2021
• Initial Date FDA Received: 12/23/2021
• Supplement Dates Manufacturer Received: 01/27/2022; 02/01/2022; 03/14/2022; 04/28/2022; 05/31/2022; 06/16/2022; 08/10/2022; 10/04/2023
• Supplement Dates FDA Received: 01/27/2022; 02/01/2022; 03/24/2022; 05/07/2022; 06/08/2022; 06/20/2022; 08/11/2022; 10/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 35 YR
• Patient Sex: Male