MAUDE Adverse Event Report: TORAX MEDICAL, INC. LINX 1.5 16 BEAD US; ANTI-REFLUX IMPLANT

Catalog Number LXMC16

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Dysphagia/ Odynophagia (1815); No Code Available (3191)

Event Date 08/23/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.Additional information was requested, and received: can you please follow-up with the surgeon and ask the following? what was the sizing technique that was used (sizing of the esophagus instructions per the ifu or another technique)? sizing based on policy and procedure did the patient have an autoimmune disease? no.Is the patient currently taking steroids / immunization drugs? no.Patient identifiers: ahb, dob: (b)(6).Patient weight: (b)(6).Patient gender: male.Date of implant: (b)(6) 2019.Date of explant: (b)(6) 2019.Device size: 16 bead clasp, lot 22959.Test performed pre-implant: barium swallow, ph and egd.Egd (b)(6) 2018: 4 cm paraesophageal hernia; esophageal changes suspicious for short segment be, antritis.Barium (b)(6) 2018: tiny sliding hiatal hernia, trace gastroesophageal reflux.Did the patient have an autoimmune disease? no.Did the patient have any pre-existing dysphagia or other conditions (other than gerd)? no.Were there any intra-operative complications during implant? no.Was there any hiatal or crural repair done at the same time as the implant? yes.Was mesh used at time of implant? no.What was the reason for removal of the linx device? ongoing dysphagia.If dysphagia, how severe was the dysphagia/odynophagia before intervention? severe.Was the device found in the correct position/geometry at the time of removal? yes.Was a replacement linx device used? no.Additional diagnostic testing or intervention performed prior to removal: egd/dilation: (b)(6) 2019, (b)(6) 2019, (b)(6) 2019.Multiple courses of iv steroids and po steroids.Esophagram (b)(6) 2019: delayed motility of ingested contrast secondary to outlet obstruction at level of linx.Esophagram (b)(6) 2019: delayed emptying at linx.Prominent intraesophageal reflux.

Event Description

It was reported that the patient had a linx implant on (b)(6) 2019, due to gerd and a paraesophageal hernia repair.After the procedure, the patient started experiencing dysphagia.The patient had three egd dilations ((b)(6) 2019, (b)(6) 2019 and (b)(6) 2019).After the visit on 7/1/2019, an explant was decided, due to prolonged dysphagia.The explant date was (b)(6) 2019.There were no issues after removal.The linx device was in place when removed.No replacement was implanted.A diagnostic laparoscopy with lysis of adhesions were performed with the linx removal.A post op visit is scheduled for (b)(6) 2019.Current patient status is unknown until that follow-up visit.

Manufacturer Narrative

(b)(4) date sent: 10/08/2019 device analysis: overall review of the device function and dimensions show no anomalies from a device that has been reasonably changed as part of the explant procedure.Visual analysis was consistent with an explanted device, and link length and tensile force were found to meet the applicable specifications.Overall, no analysis conclusions relevant to the patient experience were found.The dhr for lot 22959 was reviewed.No ncs, defects, or reworks related to the product complaint were found.

• Brand Name: LINX 1.5 16 BEAD US
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 9097773
• MDR Text Key: 162436643
• Report Number: 3008766073-2019-00466
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005363
• UDI-Public: 00855106005363
• 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
• Report Date: 08/27/2019

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: 08/27/2022
• Device Catalogue Number: LXMC16
• Device Lot Number: 22959
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2019
• Initial Date Manufacturer Received: 08/27/2019
• Initial Date FDA Received: 09/20/2019
• Supplement Dates Manufacturer Received: 09/30/2019
• Supplement Dates FDA Received: 10/08/2019
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 83