MAUDE Adverse Event Report: TORAX MEDICAL, INC. UNK LINX MAGNETIC IMPLANT; ANTI-REFLUX IMPLANT

Catalog Number UNK LINX MAGNETIC IMPLANT

Device Problems Therapeutic or Diagnostic Output Failure (3023); Migration (4003)

Patient Problems Pain (1994); No Code Available (3191)

Event Date 05/24/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The lot was not provided; therefore, the manufacturing record evaluation could not be performed.Additional information was requested, and the following was received: what is the product code for the linx device? what is the lot number for the device? what were the first clinical symptoms that provided evidence of an erosion and when did they first occur? pain behind the sternum, no possibility to eat normal food.Has the patient had any dilations, egd, or other procedure between the linx implant and discovery of the erosion? please describe and include the dates of the procedures.No dilations reported.It was reported that 4-5 beads immigrated inside.Where were the eroded beads positioned? inside = inside the lumen of esophagus / anterior.Which best describes the device removal approach? endoscopically removed the eroded beads initially & laparoscopically removed the device at a later date.Endoscopically removed the eroded beads & laparoscopically removed the device the same day.Endoscopically removed the entire device.Laparoscopically removed the entire device = yes.Was the patient stented? cardiologic stented, intraoperative stented with a stomach tube device? what is the current condition of the patient? still waiting for an answer of the surgeons.Lot, code or serial number is still unknown!.

Event Description

It was reported that the linx band was implanted on (b)(6) 2012 in (b)(6).Patient came with pain behind the sternum and could not eat solid food.Revision was on (b)(6) 2019 in (b)(6).4-5 beads immigrated inside.The implant was completely intergrown by the tissue.The surgeon has performed a partial resection of the esophagus.Current patient status unknown.Code number of the implant is not known.

Manufacturer Narrative

Pc-(b)(4).Date sent: 07/23/2019.Additional information was requested, and the following was obtained: what is the current status of the patient? what is the product code for the linx device? what is the lot number of the linx device? response: currently the patient is fine.The explant will not come back for investigation.

Manufacturer Narrative

(b)(4).Date sent: (b)(6) 2019.Per photographic evaluation: img_102: this is an intraoperative photograph which shows an exposed linx device.I am unable to determine what anatomical structure in in the surgeons hands but it does not appear to be the esophagus.Img_101:these pictures show an endoscopic view of the stomach with a linx device that has eroded into the lumen of the cardia.Img_100: this appears to be a laparoscopic photograph of the gastroesophageal junction and cardia which shows a visible linx device on the anterior surface of the cardia.Img_98: this appear to be an endocopic close up view of 2 linx beads.No linx device defects were noted in the photographs.The lot number is unknown, therefore no dhr could be performed.As the device was not returned, no conclusion relevant to the patient experience could be reached.The lot/batch was not provided; therefore, the manufacturing records could not be reviewed.

• Brand Name: UNK LINX MAGNETIC IMPLANT
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 8703687
• MDR Text Key: 148162238
• Report Number: 3008766073-2019-00369
• 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: 05/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK LINX MAGNETIC IMPLANT
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/24/2019
• Initial Date FDA Received: 06/17/2019
• Supplement Dates Manufacturer Received: 07/04/2019; 07/25/2019
• Supplement Dates FDA Received: 07/23/2019; 08/20/2019
• Patient Sequence Number: 1