MAUDE Adverse Event Report: TORAX MEDICAL, INC. LINX 1.5 16 BEAD US; ANTI-REFLUX IMPLANT

Model Number LXMC16

Device Problem Defective Component (2292)

Patient Problems Pyrosis/Heartburn (1883); No Code Available (3191)

Event Date 05/09/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.It was reported that the ¿locking mechanism failed¿.Is this referring to the multi-directional locking clasp of the linx? how was this issue diagnosed? what type of symptoms did the patient present with? when did these symptoms begin? what there any imaging done which showed the reported failure? if yes, can you please share a copy of this imaging? please send to (b)(4).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.

Event Description

It was reported that post implant of lxmc16, the locking mechanism failed.Unknown how the issue was diagnosed.The issue was resolved with the implant of a new lxmc16.Implant/explant surgeon: dr.(b)(6).Implant/explant facility: (b)(6) specialty hospital.New implant: (b)(6) 2019.

Manufacturer Narrative

(b)(4).Additional information was requested, and the following was obtained: spoke to the surgeon, the patient was experiencing gerd symptoms.The clasp was intact, but it was easier than usual to unclasp.As he was removing the device, one of the wires broke, but that was probably due to the hook cautery he was using.The surgeon replaced with a same size linx- lmc16.Patient is doing great.The dhr of lot 12720 was reviewed.No ncs, reworks, or defects were found related to the product complaint.

Manufacturer Narrative

(b)(4).Date sent: 02/10/2020.Additional information received: patient demographics: gm (dob (b)(6) 1958).

Manufacturer Narrative

(b)(4).Date sent: 01/02/2020.Additional information received: surgery to replace the original linx was done on (b)(6) 2019 d/t pt having reflux.While the linx was being removed it broke into 3 pieces.No additional imaging done since surgery.Pt did have egd w/ dilation on (b)(6) 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.Are there any in-vivo imaging of the device before the explant surgery? if yes, can you please share those images?.

Manufacturer Narrative

(b)(4).Device analysis: the device was returned in two pieces with clasp beads in an unlocked position.The initial attempt to lock the clasp beads failed due to a piece of hardened tissue on one of the clasp beads.After the tissue was removed, the clasps locked per specifications (with one visible window).The intra-clasp separation force was in-spec.The analysis of the locking mechanism does not point to any issues.Hence, the reported complaint is not confirmed.In addition, the device had an exposed weld ball presumably pulled out of the washer side of the adjacent bead during the explant procedure.The visible weld-ball and the corresponding washer through-hole diameters were scanned using computer tomography (ct).The measured washer through hole diameter was greater than the upper specification.The paired weld ball diameter was found to be within the specification.In the complaint file, it is reported that the device was intact prior to the removal.The device became discontinuous during the explant procedure.Hence, it is presumed that the cause of reflux is not related to this issue.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.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.

• Brand Name: LINX 1.5 16 BEAD US
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 8650462
• MDR Text Key: 146421209
• Report Number: 3008766073-2019-00353
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005363
• UDI-Public: 00855106005363
• Combination Product (y/n): N
• PMA/PMN Number: P100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/09/2019

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: 11/01/2020
• Device Model Number: LXMC16
• Device Catalogue Number: LXMC16
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/28/2019
• Initial Date Manufacturer Received: 05/09/2019
• Initial Date FDA Received: 05/29/2019
• Supplement Dates Manufacturer Received: 06/03/2019; 12/10/2019; 01/17/2020; 04/03/2020
• Supplement Dates FDA Received: 06/18/2019; 01/02/2020; 02/10/2020; 04/22/2020
• Patient Sequence Number: 1
• Patient Age: 60 YR