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); Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Pyrosis/Heartburn (1883); Nausea (1970); Pain (1994)

Event Date 09/01/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The dhr for lot#: 9336 was reviewed.No ncs, defects, or reworks related to the product complaint were found.Lot 9336 was an affected lot of the 2018 linx recall.Additional information was requested, and the following was obtained from the representative: device lot number lxm13; lot#: 9336 sn: (b)(4).The symptoms returned, same as pre-implant though not quite as bad.On (b)(6) 2020, sore throat in mornings, phlegm, bitter taste in mouth.Otc h2 blocker stopped sore throat, reduced other symptoms but still present.On (b)(6) 2020, ppi and arranged barium exam if still symptoms after 1 month.On (b)(6) 2020, barium exam.Taking daily ppi.No mri¿s since implantation in 2016.What was the date of implant? march 2016.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? 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.No additional images.What is the management plan? is device removal scheduled? is a replacement linx or fundoplication planned? no information on this as yet when and if the explanation takes place can we ask that the procedure gets video recorded and the video shared? no further information on this as yet when and if the linx device is removed, may we ask that the device be returned for analysis? yes that will be arranged.Additional information from the patient: i have a linx implanted which was recalled after implantation.Unfortunately, my gerd symptoms returned and i have confirmed by barium exam that it is indeed separated.What was the date of implant? (b)(6) 2016.Besides gerds what (if any) other symptoms lead to the discovery of the discontinuous device? when did they begin? only a return of my pre-implant gerd symptoms.Beginning of (b)(6) 2020.Where is the country of this event? implantation was in the (b)(6), separation was in (b)(6).What was the date of the imaging which showed the discontinuous linx? if available, please share a copy of this imaging.(b)(6) 2020.I did receive the recall notice.Was the device initially effective in controlling reflux? yes, excellent control.Came off ppi the day of surgery.Were any events associated with the onset of symptoms (vomiting, retching, trauma, surgery)? i am now back on ppi which control my morning sore throat.My gerd symptoms sometimes make me feel nauseous but never to the point of vomiting.I mainly feel the reflux during activity so once more have had to avoid physical activities.Did the you undergo an mri since device implant? if so, when was the mri and what strength? no.Did the you have any other surgeries in the area? no.What is the management plan? is device removal scheduled? is a replacement linx or fundoplication planned? have contacted my uk surgeon but things are slow with covid.My expectation is a simple replacement if possible.Photographic evaluation: as per medical safety officer: i reviewed a barium xray associated with this complaint.The xray 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.The mechanism/cause of failure cannot be determined from the x-ray image.

Event Description

It was reported that linx device looks to be open on the patient x-ray.No further details.

Manufacturer Narrative

(b)(4).Additional information received: the explant surgery is attempting to be scheduled by the end of the year.

Manufacturer Narrative

(b)(4).Date sent: 02/11/2021.Additional information received: the patient has consulted with the doctor for an explant and the procedure will be scheduled in the near future.The patient is traveling to the us for the explant procedure.

Manufacturer Narrative

(b)(4) date sent: 6/14/2021 correct data = mwr(b)(4).D6b explant date of (b)(6) 2021.

Manufacturer Narrative

(b)(4).Date sent: 05/07/2021.Additional information received: received message from patient that explant procedure has been performed.He is healing and says his voice is returning so things are going well.On (b)(6) 2021 received message from patient who indicated he¿s continuing to heal and is back in the office now.He still has a couple of symptoms but is hoping they reside soon.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.

Manufacturer Narrative

(b)(4).Date sent: 8/12/2021.The visual analysis found that the returned device had an exposed well ball paired with the male bead case of the adjacent bead.The affected male bead case through hole diameter was measured with pin gauges and was found to be greater than the specification.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.It is presumed that a certain geometric combination of the weld ball and the male bead case 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, excepting for weld ball pull through, for a device that has been reasonably changed as part of the explant procedure.

Manufacturer Narrative

(b)(4).Date sent: 4/5/2023.See op notes attached.Additional photo images were received and are pending review.When the review is completed, a supplemental medwatch will be sent with a summary of the evaluation.

Manufacturer Narrative

(b)(4).Date sent: 4/25/2023.Photo analysis: as per medical safety officer: the image demonstrates a discontinuous linx device.The mechanism/cause of failure cannot be determined from the x-ray image.The mechanism/cause of failure is unknown as a hands-on analysis of the device is necessary to determine the cause of failure.

• 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
• Manufacturer Contact: kara ditty-bovard ; 4188 lexington avenue north; shoreview, MN ; 6107428552
• MDR Report Key: 10819711
• MDR Text Key: 216100519
• Report Number: 3008766073-2020-00169
• 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: Foreign,Company Representative
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/25/2023

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2019
• Device Catalogue Number: LXM13
• Device Lot Number: 9336
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/12/2020
• Initial Date FDA Received: 11/10/2020
• Supplement Dates Manufacturer Received: 11/16/2020; 01/21/2021; 04/12/2021; 05/18/2021; 07/30/2021; 03/21/2023; 04/12/2023
• Supplement Dates FDA Received: 12/07/2020; 02/11/2021; 05/07/2021; 06/14/2021; 08/12/2021; 04/05/2023; 04/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2015
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-2038-2018
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 88 KG
• Patient Ethnicity: Non Hispanic