MAUDE Adverse Event Report: TORAX MEDICAL, INC. LS14; ANTI-REFLUX IMPLANT

Model Number LS-[14]

Device Problem Protective Measures Problem (3015)

Patient Problems Pyrosis/Heartburn (1883); No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Only event year known: 2018.Additional information was requested and the following was obtained: to date, we have not received any additional information about this patient from dr.(b)(6).Can you please follow-up to determine answers to the following questions; when available, can you please provide the following information: can you please provide further detail as to the extract of the linx band.On what date was the band explanted? do you have the linx ls14 lot number and serial number (if applicable)? did the patient have an autoimmune disease? is the patient currently taking steroids / immunization drugs? on what date was the linx device implanted in 2016? were there any intra-operative complications during implant? was there any hiatal or crural repair done at the same time as the implant? was the device found in the correct position/geometry at the time of removal? was a new linx placed after this one was removed? what is the current patient status? is the device that was explanted available for return? if yes, to whom can the return shipper kit be sent (name, address and phone number).Response: there is nothing new to report.Dr.(b)(6) has not scheduled explant surgery yet.

Event Description

It was reported that the linx device was implanted in 2016.The patient has developed reoccurring reflux post-operative.The patients doctor did an x-ray and found that the device was not continuous and informed the patient that the device needed to be explanted.There is no date scheduled for the explant at this time.

Manufacturer Narrative

(b)(6).3008766073-2019-00235.Additional information was received: removal is scheduled for 10/30.¿dr.Hass jassim has a patient with a discontinued linx device.We had to put the removal on hold, as the patient developed cancer that needed attention first.This patient is now ready for her removal.¿ 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 removal was scheduled for 10/30.Can you please confirm that the removal surgery did take place?.

Manufacturer Narrative

(b)(4).Additional information received: patient has been pushed out indefinitely.She has developed cancer and that will be treated first before her explant will be rescheduled.Per photographic evaluation: an x-ray image of the device in a discontinuous state was received.Two connected clasp beads were noted in the x-ray image.The device remains implanted and is therefore unavailable for analysis.The failure mode of the device cannot be determined as the device was not returned.It should be noted that based on the implant date (2016) - the device would have been manufactured before the 2017 corrective action for the out of spec condition associated with discontinuous linx devices and the 2018 linx recall.The device lot number is unknown, therefore no dhr review could be performed.

Manufacturer Narrative

(b)(4).Date sent: 02/08/2019.Additional information requested and received: did the device explant take place on (b)(6)? the explant was been rescheduled from (b)(6).

Manufacturer Narrative

(b)(4), date sent: 12/06/2019.Additional information received: the device was removed on (b)(6) 2019.Lot no.Unknown.

Manufacturer Narrative

(b)(4).Date sent: 02/18/2020.Per photographic evaluation: 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.Device analysis: 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.Analysis found that the returned device had an exposed weld ball paired with the washer side of the adjacent bead.The washer through-hole diameter was measured with computed tomography (ct) and found to be out of specification.The exposed weld ball diameter was found to meet specifications.The interference between the washer through-hole and the exposed weld ball diameters is 0.0005¿.It is presumed that a certain geometric combination of the weld ball and the washer through-hole resulted in the device separation in vivo.Overall review of the device function and dimensions, excluding the out of specification washer through-hole, show no anomalies from a device that has been reasonably changed as part of the explant procedure.Based on the reported implanted year of 2016, this device is affected by the 2018 linx recall.The device lot number is unknown, therefore no dhr review could be performed.,the device lot number is unknown, therefore no dhr review could be performed.

• Brand Name: LS14
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 8220503
• MDR Text Key: 132516373
• Report Number: 3008766073-2019-00235
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005035
• UDI-Public: 00855106005035
• 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,Followup
• Report Date: 12/11/2018

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 Model Number: LS-[14]
• Device Catalogue Number: LS14
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2019
• Initial Date Manufacturer Received: 12/11/2018
• Initial Date FDA Received: 01/05/2019
• Supplement Dates Manufacturer Received: 01/16/2019; 03/08/2019; 10/14/2019; 11/14/2019; 02/13/2020
• Supplement Dates FDA Received: 02/08/2019; 03/14/2019; 11/07/2019; 12/06/2019; 02/18/2020
• Patient Sequence Number: 1