MAUDE Adverse Event Report: TORAX MEDICAL, INC. LX14; ANTI-REFLUX IMPLANT

Catalog Number LX14

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

Patient Problems Dysphagia/ Odynophagia (1815); Insufficient Information (4580)

Event Date 12/07/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch # unk.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.Photo received and is pending review.When the review is completed, a supplemental medwatch will be sent with a summary of the photographic evaluation.Additional information received: the implant was (b)(6) 2013.The fact that this is an older model can be deduced from the name lx.The current generation is called lxm.The endoscopic image of the lx14 in the esophagus prior to the explanation is shown in the appendix.Three titanium beads can be clearly identified.The implant should actually be found around the feeding tube, from this picture it appears that the implant has partly migrated through the wall of the esophagus.According to today's assessment, the implant was probably selected too small and was probably placed clearly under compression at that time.Today, a linx is expressly implanted without compression.The two threads, which are permanently attached to the implant for manipulation on the implant, are now removed after the positioning of the llinx.In this case, both strings were still to be found.Intraoperatively, an unsupplied hiatus hernia was clearly visible.Today, the hiatus hernias is mandatory if a linx is used.Explanation: the implant was completely prepared laparoscopic and removed without any problems.After that, the hiatus hernia was first supplied by several seams and then a fundoplication was carried out after nissen.The perforations outside the esophagus were successfully covered by the fundoplication.The perforations are expected to heal.In order to support the healing of the perforation at the two points within the esophagus, an e-sponge was placed in the esophagus and connected to a vacuum pump (endovacc).The patient was antibiotic-treated with two different antibiotics.The operation was necessary according to the circumstances, but without complications.If information is obtained that was not available for the initial report, a follow-up report will be field as appropriate.

Event Description

It was reported that the linx implant wanders in the esophagus.An elective procedure for explant is scheduled for 10 december.Implant 2013.Patient is well.

Manufacturer Narrative

(b)(4).Date sent: 1/8/2021.The dhr for lot 4211 was reviewed.No ncs, defects, or reworks related to the product complaint were found.Photo/x-ray evaluation from medical safety officer: i reviewed an endoscopy image from the patient that showed a linx device that had eroded into the esophagus with 3 beads visible.The erosion was at the squamocolumnar junction.Additional information was requested, and the following was obtained: what symptoms lead to the discovery of the migrated linx device? the patient felt a persistent pressure and realized that food passage was slower than expected.An endoscopy showed the situation.Did the device get explanted on (b)(6) 2020? yes.

Manufacturer Narrative

(b)(4).Date sent: (b)(6) 2021.H6: deformation problem (c070601).The visual analysis of the device indicates the presence of device sutures meaning that the sutures were not removed during implant procedure.The link length was found to meet specifications.The pull test results of the returned device had one bead- to-bead junction with high separation force.The production pull test results of the device (lot number 4211 and serial number (b)(6)) were found to be within specifications.Therefore, it is presumed that the cause of the high bead-to-bead separation force is the wire that was bent during the explant procedure.Overall, no analysis conclusions relevant to the patient experience were found.

• Brand Name: LX14
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 11004243
• MDR Text Key: 221478037
• Report Number: 3008766073-2020-00201
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 12/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/12/2016
• Device Catalogue Number: LX14
• Device Lot Number: 4211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2021
• Date Manufacturer Received: 01/27/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention