MAUDE Adverse Event Report: TORAX MEDICAL, INC. 1.5T LINX, 14B; ANTI-REFLUX IMPLANT

Catalog Number LXMC14

Device Problems Migration or Expulsion of Device (1395); Patient Device Interaction Problem (4001)

Patient Problem Pyrosis/Heartburn (1883)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4); only event year known: 2020.Device remains implanted.The lot was not provided, therefore, the manufacturing record evaluation could not be performed.If further details are received at a later date, a supplemental medwatch will be sent.

Event Description

It was reported that post-implant of an unknown linx device, the patient returned with gerd symptoms.A barium swallow showed a discontinuous device.The device remains implanted, removal date is yet to be determined.Procedure: gastric procedure.

Manufacturer Narrative

(b)(4).Per the ethicon medical safety officer: i reviewed a single supine barium xray image associated with this complaint.The x-ray image showed a discontinuous linx device in the epigastric area.The annular shape was absent, and the appearance was c-shape consistent with a discontinuous device.Unfortunately, the mechanism/cause of failure cannot be determined from the provided x-ray image.Additional information was requested, and the following was obtained: what was the date of implant? (b)(6) 2016 at white in round rock tx.Besides gerd¿s were there any other symptoms lead to the discovery of the discontinuous device? when did they begin? exact date unknown but in recent months what is the product code for this complaint? lxmc14.What is the device lot number? no lot # was ever uncovered due to implantation at another institution.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? unknown.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.Unknown.What is the management plan? is device removal scheduled? is a replacement linx or fundoplication planned? device will be removed on 12/08.Possible replacement linx, if not, fundoplication.

Manufacturer Narrative

(b)(4).Date sent: 1/19/2021.Device analysis: a suture wire knotted on a wire was observed during the visual assessment.It is known that sometimes, during the explant procedure, a suture is placed on the device to aid in the extraction of the device.Hence, it is presumed that the suture was placed by the explant facility during the explant procedure.The visual analysis found that the returned device had an exposed well ball paired with the washer side of the adjacent bead.The affected washer through hole diameter was measured with pin gauges and found to be greater than the specifications.The exposed weld ball diameter was found to meet specifications.The interference between the washer through-hole and the exposed weld ball diameters was 0.00001".It is presumed that a certain geometric combination of the weld ball and the washer through-hole resulted in the device separation in vivo.Link length and tensile force were found to meet the applicable specifications during device analysis.No anomalies for a device that has been reasonably changed as part of the explant procedure.The device is affected by 2018 linx recall product bounding based on the implant date of 2016.

• Brand Name: 1.5T LINX, 14B
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 10842825
• MDR Text Key: 216324546
• Report Number: 3008766073-2020-00174
• Device Sequence Number: 1
• Product Code: LEI
• 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
• Report Date: 10/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: LXMC14
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2021
• Date Manufacturer Received: 01/06/2021
• Removal/Correction Number: Z-2038-2018
• Patient Sequence Number: 1