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

Catalog Number LXM13

Device Problems Migration or Expulsion of Device (1395); Device Appears to Trigger Rejection (1524)

Patient Problem Pyrosis/Heartburn (1883)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 12/30/2020.Only event year known: 2020.As the device was not returned, an analysis investigation could not be performed.A conclusion could not be reached as to what may have caused or contributed to the event.The dhr for lot 11844 was reviewed.No ncs, defects, or reworks related to the product complaint were found.Mfg date: 08/10/2016.Exp date: 08/10/2020.Photo/x-ray evaluation from mso: i reviewed an x-ray image associated with this complaint.This was a plain film image of the linx device.There were not enough images to provide any comment on the device.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 anymore x-ray photos that you can share about this complaint? besides reflux was there any other symptoms lead to the discovery of the discontinuous device? when did they begin? what was the date of the imaging which showed the discontinuous linx? 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.What is the management plan? is a replacement linx or fundoplication planned? when and if the explanation takes place can we ask that the procedure gets video recorded and the video shared? when and if the linx device is removed, may we ask that the device be returned for analysis? may we please reach back out to you after (b)(6) 2021 to confirm the device was explanted?.

Event Description

It was reported that the linx was broken between two beads.

Manufacturer Narrative

(b)(4).Date sent: 1/25/2021.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: was the device explanted on (b)(6) 2021?.

Manufacturer Narrative

(b)(4).Date sent: 2/19/2021 additional information was requested, and the following was obtained: was the device explanted on (b)(6) 2021? yes.Are there any more x-ray photos that you can share about this complaint? no.Besides reflux was there any other symptoms that lead to the discovery of the discontinuous device? no.What was the date of the imaging which showed the discontinuous linx? (b)(6) 2020.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? if so, when was the mri and what strength? no.Did the patient have any other surgeries in the area? no.Was any additional imaging performed since device implant? no.What is the management plan? is a replacement linx or fundoplication planned? yes, after removal on (b)(6).A foundoplication (toupet) was performed.When and if the explanation takes place can we ask that the procedure gets video recorded and the video shared? yes, the linx removal was video recorded and will be shared.When and if the linx device is removed, may we ask that the device be returned for analysis? yes, the device will be returned for analysis.

Manufacturer Narrative

(b)(4).Date sent: 3/2/2021.Device analysis: 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 and found to be greater than the specification.The exposed weld ball diameter was found to meet specifications.The interference between the washer through-hole and the exposed weld ball diameters was 0.0002.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 within the 2018 linx recall based on the reported lot number 11844.

• Brand Name: LINX 1.5T 13 BEAD OUS
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 11096370
• MDR Text Key: 224804212
• Report Number: 3008766073-2020-00204
• 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,foreig
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/10/2020
• Device Catalogue Number: LXM13
• Device Lot Number: 11844
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2021
• Date Manufacturer Received: 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Removal/Correction Number: Z-2038-2018
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention