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

Catalog Number LXMC13

Device Problem Disconnection (1171)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date of event: only event year known: 2019.Batch # unk.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.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.Is there an x-ray of the linx device prior to the automobile accident? if yes, please send a copy to (b)(4).Does the surgeon believe that the automobile accident contributed to the discontinuous device? what was the severity of the automobile accident? what symptoms lead to the discovery of the discontinuous device? when did they begin? when was the device implanted? 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? 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?.

Event Description

It was reported that post implant the patient was doing well but was recently in an automobile accident.X-ray shows a discontinuous linx device.It is unknown if there were any adverse patient consequences.Device is still implanted and will be available for return, removal tbd.

Manufacturer Narrative

(b)(4).Date sent: 09/11/2019.Additional information was requested, and the following was obtained: is there an x-ray of the linx device prior to the automobile accident? if yes, please send a copy to (b)(4).Does the surgeon believe that the automobile accident contributed to the discontinuous device? possible.What was the severity of the automobile accident? what symptoms lead to the discovery of the discontinuous device? when did they begin? when was the device implanted? (b)(6) 2016.What is the device lot number? 9756.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? no.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.I will send to you what is the management plan? is device removal scheduled? is a replacement linx or fundoplication planned? removed and new linx placed.When and if the explanation takes place can we ask that the procedure gets video recorded and the video shared?.

Manufacturer Narrative

(b)(4).Date sent: 10/29/2019.Per photographic evaluation: x-ray image of a device was received.The analysis of the x-ray image indicates a discontinuous device which is evidenced by a wide separation between two beads.The mechanism of failure cannot be established based on the x-ray image.Please refer to the device analysis for more details.Device analysis: visual analysis was consistent with an explanted device, and link length and tensile force were found to meet the applicable specifications.The remaining device characteristics show no anomalies for a device that has been reasonably changed as part of the explant procedure.Analysis found that the returned device had an exposed weld ball visible paired with the male bead case of the adjacent bead.The male bead case through hole was measured with computed tomography (ct) and was found to be out of specification.The paired weld ball diameter was found to meet specifications.Overall review of the device function and dimensions, excluding the out of specification male bead case hole, show no anomalies from a device that has been reasonably changed as part of the explant procedure.As the device was tested to 250g tensile force in production, it is presumed that a certain geometric combination of the weld ball and the washer hole resulted in the device separation in vivo.The dhr for lot 9756 was reviewed.No defects, ncrs, or reworks related to the product complaint were found.Lot 9756 was an affected lot of the 2018 linx recall.

• Brand Name: 1.5T LINX, 13B
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 8841178
• MDR Text Key: 152637233
• Report Number: 3008766073-2019-00402
• 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: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 07/15/2019

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: 12/10/2019
• Device Catalogue Number: LXMC13
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/13/2019
• Initial Date Manufacturer Received: 07/15/2019
• Initial Date FDA Received: 07/30/2019
• Supplement Dates Manufacturer Received: 08/13/2019; 10/08/2019
• Supplement Dates FDA Received: 09/11/2019; 10/29/2019
• Patient Sequence Number: 1