MAUDE Adverse Event Report: TORAX MEDICAL, INC. UNK LINX MAGNETIC IMPLANT; ANTI-REFLUX IMPLANT

Catalog Number UNK LINX MAGNETIC IMPLANT

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191); Patient Device Interaction Problem (4001)

Patient Problems Chest Pain (1776); Necrosis (1971); Hernia (2240); Insufficient Information (4580)

Event Date 01/01/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date of event: only event year known: 2021.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.No lot or batch number was provided therefore a device history could not be done.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: what was the reason for removal of the linx device? what is the product code for the linx device that was removed? on what date did the implant take place? what is the lot # for the linx device? does the patient have any of the allergies to metals? if so, what test have been done to test for metal allergies.Is the patient currently taking currently taking steroids / immunization drugs? did the patient have any pre-existing dysphagia or other conditions (other than gerd)? was there any hiatal or crural repair done at the same time as the implant? was mesh used at time of implant? at the time of removal, was the device found in the correct position/geometry at the time of removal? have the symptoms resolved since the device was explanted? 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 that a linx device was explanted on (b)(6) 2021 for unknown reasons.

Manufacturer Narrative

(b)(4).Date sent: 8/30/2021.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.No further investigation will be conducted on this complaint as the device is found to meet the specifications.Overall, no analysis conclusions relevant to the patient experience were found.

Manufacturer Narrative

(b)(4).Date sent: 8/13/2021.H6: injury (e20).Additional information was requested, and the following was obtained: what was the reason for removal of the linx device? patient was 1 week s/p repair of a very large paraesophageal hernia (~80% of the stomach in the chest) and linx placement.About 5 days after surgery the patient developed issues with a very violent cough and trouble sleeping.He combined his pain meds and sleeping meds and ended up passing out and was taken to a local hospital.During his hospitalization he complained of worsening chest pain and a ct was done which showed his linx was still at the level of the diaphragm, but it appeared his stomach had partially herniated into the chest.As soon as the patient was cleared for discharge from their local hospital the patient was brought back to foundation where a diagnostic laparoscopy was performed.It showed that the linx was at the level of the diaphragm, but approximately 50% of the stomach was herniating through the device.The device was maximally opened ad appeared to be strangulating the stomach and as such was immediately unbuckled and removed.The posterior vagus appeared disrupted at the time of explant.What is the product code for the linx device that was removed? the product was a size 16 linx.Does the patient have any of the allergies to metals? if so, what test have been done to test for metal allergies.Patient has no metal allergies.Is the patient currently taking currently taking steroids / immunization drugs? patient was not on steroids or immunosupressants.Did the patient have any pre-existing dysphagia or other conditions (other than gerd)? the patient did not have any pre-existing dysphagia other than gerd.Was there any hiatal or crural repair done at the same time as the implant? as noted above, a large 10cm paraesophageal hernia with 80% of the stomach herniating into the chest was repaired at the time of surgery.No mesh was used in the repair.Five interupted sutures were used to repair the crura, four of which were found disrupted at the time of the hernia recurrence.Due to ischemic changes resulting in necrosis, patient did require a wedge gastrectomy at the time of the device explant.Significant effort was required to reduce his stomach back out of his chest, and he will require staged operations in order to ultimately repair his paraesophageal hernia.He did require transfer to a higher level of care with icu observation post operatively and approximately a 1 week hospital stay.He was ultimately discharged to a rehab facility before returning home.The surgeon suspects the reason for failure of the hernia repair and migration of the device was the violent coughing in the early post op period, allowing the device to move before it had scarred into place.Was mesh used at time of implant? no.At the time of removal, was the device found in the correct position/geometry at the time of removal? have the symptoms resolved since the device was explanted?.

• Brand Name: UNK LINX MAGNETIC IMPLANT
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 12234621
• MDR Text Key: 268123436
• Report Number: 3008766073-2021-00144
• Device Sequence Number: 1
• Product Code: LEI
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 07/08/2021

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 Catalogue Number: UNK LINX MAGNETIC IMPLANT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2021
• Initial Date Manufacturer Received: 07/08/2021
• Initial Date FDA Received: 07/27/2021
• Supplement Dates Manufacturer Received: 07/30/2021; 08/19/2021
• Supplement Dates FDA Received: 08/13/2021; 08/30/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention