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

Catalog Number LXMC13

Device Problems Device Appears to Trigger Rejection (1524); Inadequacy of Device Shape and/or Size (1583); Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Chest Pain (1776); Dysphagia/ Odynophagia (1815); Pyrosis/Heartburn (1883); No Code Available (3191)

Event Date 10/29/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 11/15/2019.The lot was not provided; therefore, the manufacturing record evaluation could not be performed.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported that during a visit to the patient¿s doctor where a chest x-ray was performed it was found that the linx device is discontinuous.It is in the shape of a c (in an open state, not circular).The patient was not having any adverse consequences as a result of the device malfunction.The patient¿s surgeon was contacted and informed of the situation by her physician.An explant date has not been scheduled until the surgeon can see the patient and determine which course of action to take.

Manufacturer Narrative

(b)(4).Date sent: 12/18/2019.Additional information was requested and the following was obtained: what was the date of implant? (b)(6) 2017.What is the product code of the linx device? model # lxmc13.What is the device lot number? 14973.What symptoms lead to the discovery of the discontinuous device? when did they begin? dysphagia and heartburn.What was the date of the imaging which showed the discontinuous linx? if available, please share a copy of this imaging.(b)(6) 2019.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? was any additional imaging performed since device implant? does the device appear to be in a continuous annular state in these images? last imaging, we had from (b)(6) 2018 showed the links to be in good position however subsequently there is an x-ray from (b)(6) that showed that it had disrupted.He is on the linx recall list.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 the broken linx and patient seems to be completely asymptomatic at this stage.Is device removal scheduled? not yet! is a replacement linx or fundoplication planned? no.

Manufacturer Narrative

(b)(4).Date sent: 01/30/2020.Additional information was requested, and the following was obtained: is the image from the x-ray that was taken on (b)(6) 2019 available? no.

Manufacturer Narrative

(b)(4).Date sent: 03/04/2020.Additional information was requested, and the following was obtained: we are needing to know if the explant procedure has been scheduled or possibly has taken place? can you please provide an update? no, explant has not been scheduled yet.Per photographic evaluation: two x-ray images of the device were received.Based on the review of the x-ray images, 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 and cause of failure cannot be determined from the x-ray images.The dhr for lot 14973 was reviewed.Two nc records were found to 100% inspect male bead cases for over-sized through-hole diameter.As part of one of the nc activities, two male bead cases with an oversized through hole diameter were found during 100% pinning at the supplier.No other reworks, ncs, or defects were found.

Manufacturer Narrative

(b)(4) date sent: 03/25/2020.Additional information: noting has been scheduled to date regarding the explant procedure.He felt that this would be delayed an extended period of time.

Manufacturer Narrative

(b)(4).Date sent: 9/3/2021.Photo was provided for review by ethicon medical safety officer.Following are their observations: i reviewed a lateral and ap x-ray image of the patient referred to in the complaint.The xray image showed a discontinuous clasp linx device.The annular shape was absent, the beads were separated and not in the same plane consistent with a discontinuous device.The mechanism and cause of failure cannot be determined from the x-ray images.Additional information was provided: what symptoms lead to the discovery of the discontinuous device? when did they begin? on (b)(6) 2019, patient went to er for chest pain and when they did an x-ray they noticed the device was open.Patient was diagnosed with flu.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.The last imaging we have is an upper gi from on (b)(6) 2018 and the device was intact.What is the management plan? explant on (b)(6) 2021.Is device removal scheduled? yes, it happened on (b)(6) 2021.Is a replacement linx or fundoplication planned? no, just removal of the linx was performed.The hiatus was intact.When and if the explanation takes place can we ask that the procedure gets video recorded and the video shared? no, too late.It happened yesterday.

Manufacturer Narrative

(b)(4).Date sent: 10/4/2021.Investigation summary: a 13-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.These tests allow for non-destructive review of the device including the internal features.The male bead case through-hole at the separation was measured.And was greater than the specification.The male bead case trough hole was concentric with a small amount of material displacement at the outer and inner edges of the trough hole.Optical microscopy and sem images indicate the through-hole was enlarged until the chamfer was no longer visible.These observations indicate that the cause of the oversized through-hole diameter at the failed link was likely wear of material.The through-hole geometry in some of the other washers and male bead cases had an hour-glass shape, possibly, from wear or handling during manufacturing or machining by the supplier or a combination of these.It is unknown whether the through-hole at the failed link was within specification prior to the implant procedure.However, the male bead cases that were consumed in the production of (b)(4) device were 100% sorted via pinning method by either the supplier or torax.The exposed weld ball diameter was measured within specification.The weld ball appeared to be spherical and concentric with respect to the wire.

Manufacturer Narrative

(b)(4).Date sent: 1/31/2022.Investigation summary: a 13-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.In addition, the cross-section of several beads were imaged with an optical microscope.The male bead case through-hole at the separation was measured which was greater than the specification.The male bead case trough hole was concentric with a small amount of material displacement at the outer and inner edges of the trough hole.Optical microscopy and sem images indicate the through-hole was enlarged until the chamfer was no longer visible.These observations indicate that cycling wear was a contributing cause of the oversized through-hole diameter at the failed link.The through-hole geometry in some of the other washers and male bead cases had an hour-glass shape, possibly, from wear or handling during manufacturing or machining by the supplier or a combination of these.It is unknown whether the through-hole geometry (inner diameter, chamfer, etc.) at the failed link was within specification prior to the implant procedure.However, the male bead cases that were consumed in the production of (b)(4) device were 100% sorted via pinning method by either the supplier or torax.The exposed weld ball diameter was measured which is within specification.The weld ball appeared to be spherical and concentric with respect to the wire.The dhr for lot 14973 was reviewed.Two nc records were found to 100% inspect male bead cases for over-sized through-hole diameter.As part of one of the nc activities, two male bead cases, out of over 5,000 components, with an oversized through hole diameter were found during 100% pinning at the supplier.No other reworks, ncs, or defects were found.

• Brand Name: 1.5T LINX, 13B
• 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, MN ; 6107428552
• MDR Report Key: 9327706
• MDR Text Key: 166761656
• Report Number: 3008766073-2019-00542
• Device Sequence Number: 1
• Product Code: LEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/16/2021
• Device Catalogue Number: LXMC13
• Device Lot Number: 14973
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/29/2019
• Initial Date FDA Received: 11/15/2019
• Supplement Dates Manufacturer Received: 12/05/2019; 01/10/2020; 02/05/2020; 03/24/2020; 08/18/2021; 10/01/2021; 01/28/2022
• Supplement Dates FDA Received: 12/18/2019; 01/30/2020; 03/04/2020; 03/25/2020; 09/03/2021; 10/04/2021; 01/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1