MAUDE Adverse Event Report: TORAX MEDICAL, INC. 1.5T LINX, 15B; ANTI-REFLUX IMPLANT

Catalog Number LXMC15

Device Problem Patient-Device Incompatibility (2682)

Patient Problem No Code Available (3191)

Event Date 05/10/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional information was requested, and the following was obtained: what is the exact product code? lxmc15.What symptoms lead to the discovery of the discontinuous device? when did they begin? 4 or 5 months ago suddenly started having heartburn issues and began taking otc heartburn medications.No difficulty swallowing.What was the date of the imaging which showed the discontinuous linx? (b)(6) 2019.What is the device lot number? 12446.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? no.Did the patient have any other surgeries in the area? no.Was any additional imaging performed since device implant? no.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? explant scheduled on (b)(6) 2019, patient would like to have his linx replaced.Surgeon will replace it if anatomically possible.Otherwise, he will perform a nissen after removal.

Event Description

It was reported ¿a linx device was implanted on (b)(6) 2017 and reported that patient suddenly started with heartburn issues in 2019 and it was discovered that this is a discontinuous linx device.Explant scheduled on (b)(6) 2019, patient would like to have his linx replaced.Surgeon will replace it if anatomically possible.Otherwise, he will perform a nissen after removal.¿.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).Date sent: 09/12/2019.Per photographic evaluation: an x-ray showing a discontinuous linx device was received.The linx device remains implanted and has therefore not yet been returned.The mechanism/cause of failure cannot be determined from the x-ray provided.The dhr of lot 12446 was reviewed.No ncs, reworks, or defects related to the product complaint were found.Lot 12446 is an affected lot of the 2018 linx recall.

Manufacturer Narrative

(b)(4).Date sent: 01/08/2020.The 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, excepting the visible weld ball, 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 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.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.

• Brand Name: 1.5T LINX, 15B
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 8900820
• MDR Text Key: 154557219
• Report Number: 3008766073-2019-00417
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005356
• UDI-Public: 00855106005356
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/30/2019

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: 10/12/2020
• Device Catalogue Number: LXMC15
• Device Lot Number: 12446
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/15/2019
• Initial Date Manufacturer Received: 07/30/2019
• Initial Date FDA Received: 08/16/2019
• Supplement Dates Manufacturer Received: 08/15/2019; 11/15/2019; 01/06/2020
• Supplement Dates FDA Received: 09/12/2019; 12/04/2019; 01/08/2020
• Removal/Correction Number: Z-2038-2018
• Patient Sequence Number: 1