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

Model Number LXMC14

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Dysphagia/ Odynophagia (1815); Pyrosis/Heartburn (1883); Failure of Implant (1924); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4), only event year is known: 2020.The lot was not provided; therefore, the manufacturing record evaluation could not be performed.Additional follow-up will be sent after the reported explant date.If additional information is received a supplemental medwatch will be sent.

Event Description

It was reported that the lxmc14 will be explanted on (b)(6) 2020.Rep stated discontinued or interrupted device that either the clasp is off or one of the beads is broke or the arm is broken.Recall was mentioned but lot number is unknown.

Manufacturer Narrative

(b)(4).Date sent: 08/27/2020.

Manufacturer Narrative

(b)(4).Date sent: 09/21/2020.Additional information was requested, and the following was received: was the device explanted on (b)(6) 2020? yes, replaced with a lxmc15 at the time of removal what is the lot number for the lxmc14 device? lot # 12928.When was the device implanted? (b)(6) 2017.What symptoms lead to the discovery of the discontinuous device? when did they begin? chest x ray (unrelated reason) - the patient has no symptoms and has not had any symptoms.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.What was the date of the imaging which showed the discontinuous linx? (b)(6) 2020.Did the patient undergo an mri since device implant? no.Was any additional imaging performed since device implant? ¿informal¿ x-ray done (b)(6) 2018¿date and image not saved.The patient underwent a dilation for dysphagia around that time, she is not sure if the dilation was before or after the x-ray.Does the device appear to be in a continuous annular state in these images? yes, the image showed an intact linx device.The patient began to experience gerd symptoms over the last year, had symptoms of shortness of breath, unrelated to linx so went in for the x-ray in (b)(6) 2020 which showed the discontinuous device.Per photographic evaluation: per medical safety officer: reviewed a supine abdominal/chest x-ray associated with this compliant.There was no contrast.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.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 with pin gauges 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 0.00015".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 dhr for lot 12928 was reviewed.No ncs, defects, or reworks related to the product complaint were found.The device is within the 2018 linx recall based on the reported lot number 12928.

• 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: 10297862
• MDR Text Key: 201665157
• Report Number: 3008766073-2020-00101
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005349
• UDI-Public: 00855106005349
• 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: 06/27/2020

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: 11/18/2020
• Device Model Number: LXMC14
• Device Catalogue Number: LXMC14
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/26/2020
• Initial Date Manufacturer Received: 06/27/2020
• Initial Date FDA Received: 07/20/2020
• Supplement Dates Manufacturer Received: 08/07/2020; 08/28/2020
• Supplement Dates FDA Received: 08/27/2020; 09/21/2020
• Removal/Correction Number: Z-2038-2018
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR