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

Model Number LXMC13

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 06/12/2020.Event date: unknown.Abdominal x-ray reviewed by ethicon medical: the image appeared to be a supine abdominal x-ray.There was an obvious discontinuous linx device seen in the epigastric area.The annular shape was absent, and the appearance was c-shape consistent with a discontinuous device.The anatomical location appears consistent with a device placed in the correct position at the cardia.Additional information received: on what date was the device explanted? explanted on (b)(6) 2020.Did the patient have an autoimmune disease? no.Is the patient currently taking steroids / immunization drugs? no.On what date was the linx device implanted? unknown.Were there any intra-operative complications during implant? no.Was there any hiatal or crural repair done at the same time as the implant? yes.Was the device found in the correct position/geometry at the time of removal? no.The device was discontinuous.Was a new linx placed after this one was removed? no.What is the current patient status? unknown.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.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?.

Event Description

It was reported that the ¿linx device lxmc13 will be explanted (date unknown).Patient had chest x-ray for no- related complaint.X ray showed discontinuous linx.Patient has no gerd related symptoms.

Manufacturer Narrative

(b)(4).Date sent: 07/13/2020.The dhr for lot 19538 was reviewed.No ncs, defects, or reworks related to the product complaint were found.

Manufacturer Narrative

(b)(4).Date sent: 9/16/2020.Device analysis: the visual analysis found that the returned device had an exposed well ball paired with the male bead of the adjacent bead.The affected male bead case through hole diameter was measured with computed tomography (ct) and found to be greater than the specification.A slight rim was noted on the outer edge of the through-hole.No conclusions could be made whether the cause of the rim is supplier-related (machining process) or user-related.However, since this outer rim is only present on the outer surface of the male bead case and doesn't extend to the smallest diameter of the through-hole, it is not thought to have contributed to the weld ball pull through.The exposed weld ball diameter was found to meet specifications.The interference between the male bead case through hole and the exposed weld ball diameters was 0.0004".These measurements were confirmed during the ct analysis.The ct analysis of the inner structure of the beads at the disconnected junction did not find any evidence of part deformation that could have contributed to the failure.It is presumed that a certain geometric combination of the weld ball and the washer through-hole resulted in the device separation in vivo.The link length and tensile force were found to meet the applicable specifications.The remaining device characteristics, excepting the visible weld ball, show no anomalies for a device that has been reasonably changed as part of the explant procedure.

Manufacturer Narrative

(b)(4).Date sent: 08/28/2020.

• Brand Name: 1.5T LINX, 13B
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 10148220
• MDR Text Key: 195089789
• Report Number: 3008766073-2020-00077
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005332
• UDI-Public: 00855106005332
• 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: 05/21/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2022
• Device Model Number: LXMC13
• Device Catalogue Number: LXMC13
• Device Lot Number: 19538
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/21/2020
• Initial Date FDA Received: 06/12/2020
• Supplement Dates Manufacturer Received: 06/15/2020; 08/11/2020; 09/11/2020
• Supplement Dates FDA Received: 07/13/2020; 08/28/2020; 09/16/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention