MAUDE Adverse Event Report: TORAX MEDICAL, INC. 1.5T LINX, 17 BEADS; ANTI-REFLUX IMPLANT

Model Number LXMC17

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 01/01/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date of event: only event year known: 2021.Additional information received: spoke with patient who indicated we have permission to speak directly with dr.(b)(6) office to obtain information needed.He is waiting to be scheduled for explant once the surgeon has an opening in the surgery schedule.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 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 symptoms lead to the discovery of the discontinuous device? when did they begin? what was the date of the imaging which showed the discontinuous linx? if available, please share a copy of this imaging.What is the device lot number? was the device initially effective in controlling reflux? were any events associated with the onset of symptoms (vomiting, retching, trauma, surgery)? did the patient undergo an mri since device implant? if so, when was the mri and what strength? did the patient have any other surgeries in the area? was any additional imaging performed since device implant? does the device appear to be in a continuous annular state in these images? we are interested in establishing a window when the device may have become discontinuous.Please share any additional images.What is the management plan? is device removal scheduled? when is the device removal scheduled? if the device has been removed, what was the date of explant? is a replacement linx or fundoplication planned? when and if the explanation takes place can we ask that the procedure gets video recorded and the video shared? when and if the linx device is removed, may we ask that the device be returned for analysis?.

Event Description

It was reported that a linx device is discontinuous and will be explanted.

Manufacturer Narrative

(b)(4).Date sent: 1/28/2022.Additional information received: sent message to patient and (b)(6) in dr.(b)(6) office to inquire as to whether explant has been scheduled.Will update file once response is received.Spoke with (b)(6) in dr.(b)(6) office.Explant has not been scheduled yet as elective procedures were canceled due to covid and dr.(b)(6) was on medical leave.He will return in the next two weeks and the surgery will be scheduled.

Manufacturer Narrative

(b)(4).Date sent: 1/28/2022.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 lot number 17112, and no non-conformances were identified.Additional information was requested, and the following was obtained: what symptoms lead to the discovery of the discontinuous device? when did they begin? starting having symptoms again.What was the date of the imaging which showed the discontinuous linx? if available, please share a copy of this imaging.What is the device lot number? 17112.Was the device initially effective in controlling reflux? yes.Were any events associated with the onset of symptoms (vomiting, retching, trauma, surgery)? no.Did the patient undergo an mri since device implant? if so, when was the mri and what strength? yes, several 1.5.Did the patient have any other surgeries in the area? no.Was any additional imaging performed since device implant? does the device appear to be in a continuous annular state in these images? we are interested in establishing a window when the device may have become discontinuous.Please share any additional images.What is the management plan? remove and replace.Is device removal scheduled? not yet.When is the device removal scheduled? not yet.If the device has been removed, what was the date of explant? not rescheduled yet.Is a replacement linx or fundoplication planned? replacement linx.When and if the explanation takes place can we ask that the procedure gets video recorded and the video shared? yes.When and if the linx device is removed, may we ask that the device be returned for analysis? yes.

Manufacturer Narrative

(b)(4).Date sent: 2/16/2022.Photo analysis: images of the device in vivo were received and reviewed by the medical safety officer: the device is certainly discontinuous.The mechanism and cause of failure cannot be determined from the x-ray images.

Manufacturer Narrative

(b)(4).Date sent: 02/02/2022.Additional information received: ¿ date of implant ¿ (b)(6) 2017.¿ date of symptom onset - (b)(6) 2020.¿ model# lxmc17.¿ lot# 17112.¿ any mri since implantation ¿ (b)(6) 2020, ¿ any trauma to that area of the body- no.¿ when was kidney ca dx- 2019 hx of partial nephrectomy.¿ allergies- nka.

Manufacturer Narrative

(b)(4); date sent: 3/17/2022.Additional information received: ai from (b)(6): 3/7/22 received message from (b)(6) office.Patient has been scheduled for explant on (b)(6) 2022.Shipper kit and replacement device should be sent to (b)(6).Information is below: (b)(6).

Manufacturer Narrative

(b)(4).Date sent: 5/23/2022.

Manufacturer Narrative

(b)(4).Date sent: 6/17/2022.Investigation summary: a 17-bead linx device with a visible weld ball that disconnected from a male bead case was returned to the analysis site.The link length and tensile force measurements were found to meet the applicable specifications during device analysis.The device was scanned using computer tomography (ct), optical microscopy, and scanning electron microscopy.The male bead case through-hole at the separation was measured which was greater than the specification.The male bead case through-hole was concentric with small amount of material displacement on the outer edge of the through hole.The overall appearance of the surface of the male bead case didn't exhibit gross loss of shape.The top view of the exposed weld ball diameter was measured which was within specification.The weld ball appears to be spherical and concentric with respect to the wire.

• Brand Name: 1.5T LINX, 17 BEADS
• 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: 13003765
• MDR Text Key: 282715169
• Report Number: 3008766073-2021-00260
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005370
• UDI-Public: 00855106005370
• 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,Followup,Followup,Followup
• Report Date: 06/17/2022

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: 10/20/2021
• Device Model Number: LXMC17
• Device Catalogue Number: LXMC17
• Device Lot Number: 17112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/06/2021
• Initial Date FDA Received: 12/14/2021
• Supplement Dates Manufacturer Received: 01/28/2022; 01/28/2022; 01/28/2022; 02/15/2022; 03/07/2022; 05/03/2022; 06/08/2022
• Supplement Dates FDA Received: 01/28/2022; 01/28/2022; 02/02/2022; 02/16/2022; 03/18/2022; 05/23/2022; 06/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention