MAUDE Adverse Event Report: TORAX MEDICAL, INC. 1.5T LINX, 15B; ANTI-REFLUX IMPLANT

Catalog Number LXMC15

Device Problem Device Damaged by Another Device (2915)

Patient Problem No Code Available (3191)

Event Date 09/04/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 09/24/2019.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.The lot was not provided; therefore, the manufacturing record evaluation could not be performed.Additional information was requested, and the following was obtained: what is the lot number for the linx device? na.Was ph testing performed prior to explant to confirm recurrent reflux? no.After implant, was the device initially effective in controlling reflux? yes.When did the recurrent reflux begin? month before explant.What symptoms lead to the discovery of the discontinuous device? reflux.When did they begin? month prior to explant.What was the date of the imaging which showed the discontinuous linx? a week prior to the explant.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? na.Was any additional imaging performed since device implant? no.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 after explant a similar device was implanted.Please provide the product code and lot number for the replacement device.I need to retrieve that from the hospital.

Event Description

It was reported that post implant of the lxmc15 the wire pulled out of one of the beads and the patient gerd symptoms returned.The device was explanted on (b)(6) 2019 with no patient consequences.A similar device was implanted.

Manufacturer Narrative

(b)(4).Date sent: 11/21/2019.Device analysis: an x-ray of the device in a discontinuous was received.Visual analysis was consistent with an explanted device, and link length and tensile force (with the exception of the extra peaks due to bent wires) 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 washer side of the adjacent bead.The washer through hole was measured with computed tomography and 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 washer hole, show no anomalies from a device that has been reasonably changed as part of the explant procedure.It was noted that bent wires and bead toggle resulted in small force peaks between bead separations.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 lot number is unknown; therefore, the dhr could not be reviewed.Based on the date of implant ((b)(6) 2016), the device is an affected lot of the 2018 linx recall.

Manufacturer Narrative

(b)(4).

• Brand Name: 1.5T LINX, 15B
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 9110225
• MDR Text Key: 162644973
• Report Number: 3008766073-2019-00474
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005356
• UDI-Public: 00855106005356
• 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
• Report Date: 09/04/2019

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 Catalogue Number: LXMC15
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/30/2019
• Initial Date Manufacturer Received: 09/04/2019
• Initial Date FDA Received: 09/24/2019
• Supplement Dates Manufacturer Received: 09/30/2019; 11/15/2019
• Supplement Dates FDA Received: 10/15/2019; 11/21/2019
• Patient Sequence Number: 1