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

Model Number LXMC15

Device Problems Migration or Expulsion of Device (1395); Device Appears to Trigger Rejection (1524); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Abdominal Pain (1685); Dysphagia/ Odynophagia (1815); Pyrosis/Heartburn (1883); Muscle Spasm(s) (1966); Nausea (1970); Vomiting (2144); Abdominal Distention (2601); Cramp(s) /Muscle Spasm(s) (4521); Insufficient Information (4580)

Event Date 07/31/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 8/24/2020.Additional information was requested, and the following was received: patient had symptoms of abdominal pain, bloating, constipation, dysphagia, gerd, nausea, and vomiting for a few weeks prior to her admission on (b)(6) 2020.She had a ugi on (b)(6) 2020 for further evaluation of her nausea and vomiting and it revealed disruption of the continuity of the linx device, which remains at the ge junction.She was also noted to have prominent tertiary esophageal contractions with focal transient spasm in the distal esophagus and reflux.The linx implant date was (b)(6) 2017.The device was initially effective at controlling her reflux.She is currently taking prilosec 20 mg daily.Patient did complain of nausea, vomiting, and dysphagia which led to obtaining the ugi on (b)(6) 2020.Patient did not have a mri since her device implant.She has not had any other surgeries in that area.Patient did have an ugi on (b)(6) 2018 that showed that the linx device was in place.Surgery to remove the linx device is not scheduled at this time.Patient wishes to follow up with dr.Levoyer in his office to discuss surgical explant of the linx device and options for anti-reflux surgery once she has another medical issue taken care of first.We will notify you once surgery has been scheduled.

Event Description

It was reported that the patient presented with abdominal pain and bloating.The patient had a linx device implanted in (b)(6) 2017.An x-ray showed that the device has come apart and will have to be removed.A date for the removal date has not been scheduled.

Manufacturer Narrative

(b)(4).Date sent: 11/10/2020.H6: patient code = surgical procedure.Additional information" the patient underwent robotic-assisted linx explant, hiatal hernia repair, and toupet fundoplication on (b)(6) 2020.Per photographic evaluation: as per medical safety officer.He reviewed a plain and contrast chest xray associated with this compliant.Both images showed an obvious discontinuous linx device 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.Contrast was seen in both the stomach and esophagus.There appeared to be a small hiatal hernia on the contrast film.The dhr for lot 14606 was reviewed.No ncs, defects, or reworks related to the product complaint were found.

Manufacturer Narrative

(b)(4).Date sent: 9/24/2020 the dhr for lot 14606 was reviewed.No ncs, defects, or reworks related to the product complaint were found.Analysis of photo: as per medical safety officer.He reviewed a plain and contrast chest xray associated with this compliant.Both images showed an obvious discontinuous linx device 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.Contrast was seen in both the stomach and esophagus.There appeared to be a small hiatal hernia on the contrast film.Additional information was received: video has been received and is pending evaluation.Please see attached medical records.

Manufacturer Narrative

(b)(4).Date sent: 09/24/2020.Additional information received: please see attached medical records.

Manufacturer Narrative

(b)(4).Date sent: 10/6/2020 additional information: videos were reviewed by the ethicon medical safety officer and upon his review there was no change to his assessment which was previously reported under (b)(4).

Manufacturer Narrative

(b)(4).Date sent: 12/2/2020.6.Health effect - clinical code: gastrointestinal system (e10).Additional information received: maude report received: mw5097315.Device analysis: the visual analysis found that the returned device had an exposed well ball paired with a male bead case of the adjacent bead.The exposed weld ball diameter was found to meet the specifications.The interference between the male bead case through-hole and the exposed weld ball diameters was approximately 0.0001.The ct analysis of the inner structure of the beads at the disconnected junction did not find any evidence of part deformation that could have contributed to the failure.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.The 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.

• 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: 10442888
• MDR Text Key: 204191389
• Report Number: 3008766073-2020-00130
• 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: health professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/31/2020

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: 04/14/2021
• Device Model Number: LXMC15
• Device Catalogue Number: LXMC15
• Device Lot Number: 14606
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2020
• Initial Date Manufacturer Received: 07/31/2020
• Initial Date FDA Received: 08/24/2020
• Supplement Dates Manufacturer Received: 08/28/2020; 08/28/2020; 09/28/2020; 10/13/2020; 11/05/2020
• Supplement Dates FDA Received: 09/24/2020; 09/24/2020; 10/06/2020; 11/10/2020; 12/03/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR