MAUDE Adverse Event Report: TORAX MEDICAL, INC. 1.5T LINX, 14B; ANTI-REFLUX IMPLANT

Catalog Number LXMC14

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.The lot was not provided; therefore, the manufacturing record evaluation could not be performed.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.When was the device implanted? what is the product code for the linx device? what is the device lot and serial 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? 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 surgery will take place on a later date as it was confirmed disconnected device within a patient.Patient is having issues.Device remains implanted.No other information known at this time.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).Date sent: 05/29/2019.Additional information received: implant date: (b)(6) 2016.Implant location: (b)(6).Linx size: 14.Removal reason: recurrent gerd symptoms for about 3-5 months.Note: patient had multiple mris but stated they were all 1.5t mri.Message received from (b)(6) that they explanted the device and did not replace it.Has the explant procedure taken place? yes.If yes, on what date did this take place? (b)(6) 2019.What is the product code for the device? lxmc14.If available, what is the lot number for the device? unknown, done at outside facility what symptoms lead to the discovery of the discontinuous device? recurrent gerd symptoms.When did they begin? about 3-5 months prior to explant date.What was the date of the imaging which showed the discontinuous linx? na.If available, please share a copy of this imaging.Na.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, multiple 1.5t mris according to patient, dates not available.Did the patient have any other surgeries in the area? na.Was any additional imaging performed since device implant? na.Does the device appear to be in a continuous annular state in these images? na.We are interested in establishing a window when the device may have become discontinuous.Please share any additional images.If images and video of the explant is available, please send to (b)(6).Na.Based on the implant date, this device is affected by the 2018 linx recall.

Manufacturer Narrative

(b)(4).Date sent: 09/12/2019.Device analysis: visual analysis was consistent with an explanted device, and link length was found to meet the applicable specifications.Overall review of the device function and dimensions, excluding the out of specification washer hole and a low separation force (see discussion below), show no anomalies from 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 (ct) and found to be out of specification.The paired weld ball diameter was found to meet specifications.Force testing found that one bead appeared to be partially demagnetized, with a separation force of 10-15 gf.All other peaks were within specification.It was reported that the patient had multiple 1.5t mris.Linx devices are 100% inspected for bead separation force during the manufacturing process.Although the cause of the low separation force is unknown, the magnets of the linx device can only be demagnetized in vivo by exposure to an mri field greater than labeling.It may be the case that the patient underwent an mri greater than labeling at an outside facility (the patient¿s complete medical record may not be available to the explanting surgeon).While low separation force may lead to recurrent acid reflux, the low separation force is not related to the discontinuous linx device (caused by the out of specification thru-hole).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 device was found to be manufactured (based on the implant date, (b)(6) 2016) prior to the initiation which investigated device pull-through.This product issue was previously escalated, which resulted in the april 2018 linx recall for the through hole out of specification condition.No further corrective action is required at this time.The lot number is unknown, therefore no dhr review could be performed.

• Brand Name: 1.5T LINX, 14B
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 8582020
• MDR Text Key: 144125135
• Report Number: 3008766073-2019-00333
• 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,Followup
• Report Date: 04/11/2019

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: LXMC14
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/31/2019
• Initial Date Manufacturer Received: 04/11/2019
• Initial Date FDA Received: 05/06/2019
• Supplement Dates Manufacturer Received: 05/09/2019; 05/31/2019; 08/15/2019
• Supplement Dates FDA Received: 05/29/2019; 06/18/2019; 09/12/2019
• Patient Sequence Number: 1