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

Model Number LXMC13

Device Problem Nonstandard Device (1420)

Patient Problems Pyrosis/Heartburn (1883); No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 12/13/2019.Date of event: only event year known: 2019.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 date of implant? what symptoms lead to the discovery of the discontinuous device? when did they begin? 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.It was reported that the removal is scheduled for (b)(6) 2019.Can you please notify us when this procedure has been done? we will have to update our records.Thank you.Is the surgeon replacing the linx or is 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? please provide a contact name and mailing address for the return kit.Thank you.

Event Description

It was reported, that a discontinuous linx device (lxmc13) was identified via x-ray.Removal is planned on (b)(6) 2019.

Manufacturer Narrative

(b)(4).Date sent: 03/11/2020.Device analysis: the 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, excepting the visible weld ball, 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 washer side of the adjacent bead.The smallest washer through-hole diameter was measured with computed tomography (ct) and found to be greater than the specification.The exposed weld ball diameter was measured as was within specification.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.

Manufacturer Narrative

(b)(4).Date sent: 01/10/2020.Per photographic evaluation: an x-ray image of the device in vivo was received.The device doesn't seem to have the expected annular shape in the x-ray images.The "c" shape of the device seems consistent with a discontinuous device.The mechanism/cause of failure cannot be determined from the x-ray provided.The reported lot number 11739 is not associated with a finished goods lot number.Since, the device lot number is unknown, the device history record could not be reviewed.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.11739 was reported as a lot number for the complaint device, lxmc13.However, this corresponds as a serial number for the reported complaint device, lxmc13.The following is requested: what is the lot number for the lxmc13 linx device? can you please confirm that the 11739 is the serial number associated with the lxmc13 complaint device? additional information received: the explant procedure and re-implant surgery was scheduled for (b)(6).It was confirmed that the explant did take place on (b)(6) and the linx was replaced.What was the date of implant? (b)(6) 2018.What symptoms lead to the discovery of the discontinuous device? recurrent gerd when did they begin?(b)(6).Was the device initially effective in controlling reflux? yes, very effective.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 mris.Did the patient have any other surgeries in the area? no other surgeries was any additional imaging performed since device implant? yes, upper gi.Does the device appear to be in a continuous annular state in these images? no, it appears to be discontinuous which is why we removed it.We are interested in establishing a window when the device may have become discontinuous.Please share any additional images.No additional images.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: 02/12/2020.Additional information was requested, and the following was obtained: what is the lot number for the lxmc13 linx device? 8095.Can you please confirm that the (b)(6) is the serial number associated with the lxmc13 complaint device? yes, correct serial number.The dhr for lot 8095 was reviewed.No ncs, defects, or reworks related to the product complaint were found.Lot 8095 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: 9465650
• MDR Text Key: 173698341
• Report Number: 3008766073-2019-00557
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Model Number: LXMC13
• Device Catalogue Number: LXMC13
• Device Lot Number: 11739
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2020
• Date Manufacturer Received: 02/25/2020
• Removal/Correction Number: Z-2038-2018
• Patient Sequence Number: 1