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

Catalog Number UNK LINX MAGNETIC IMPLANT

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Dysphagia/ Odynophagia (1815); Pain (1994); Pneumothorax (2012); Blood Loss (2597); Abdominal Distention (2601); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date of event: unknown.The lot was not provided; therefore, the manufacturing records could not be reviewed.If further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported via journal article: title: magnetic sphincter augmentation and fundoplication for gerd in clinical practice: one-year results of a multicenter, prospective observational study.Author/s: martin riegler ¿ sebastian f.Schoppman ¿ luigi bonavina ¿ david ashton ¿ thomas horbach ¿ matthias kemen.Citation: surg endosc.2015; 29: 1123¿1129.Doi: 10.1007/s00464-014-3772-7.The techniques available for antireflux surgery have expanded with the introduction of the magnetic sphincter augmentation device (msad) for gastroesophageal reflux disease (gerd).In this report, the authors explore the clinical experience and insights gained from a large multicenter registry that enrolled patients treated with either msad or lf in the clinical practice setting to better understand and define the role of msad and lf for gerd.A prospective, multicenter registry evaluated msad and laparoscopic fundoplication (lf) in clinical practice were collected in 249 patients (202 msad patients; age: 46.6 ± 13.9 years; 61.7% male and 38.3% female patients; bmi: 25.7 ± 3.8 and 47 lf patients; age: 52.8 ± 12.8; 60.0% male and 40.0% female patients; bmi: 26.1 ± 5.3).The msad, linx reflux management system (ethicon) was developed as an alternative surgery to fundoplication for augmenting the lower esophageal sphincter (les) in treating gerd.The msad replaces the reconstruction of the gastric fundus with an implantable device consisting of a ring of connected magnetic beads.Reported complications in the msad group included bloaty and gassy feeling (n-10.0), difficulty swallowing (n-7.0), inability to belch or vomit, minor bleeding (n-2) with no clinical consequences, post-operative dysphagia (n-1), pneumothorax (n-1), dysphagia which required re-operation and device removal, pain which required re-operation and device removal, and persistent gerd which required re-operation and device removal.Antireflux surgery should be individualized to the characteristics of each patient, taking into consideration anatomy and propensity and tolerance of side effects.Both msad and lf showed significant improvements in reflux control, with similar safety and reoperation rates.In the treatment continuum of antireflux surgery, msad should be considered as a first-line surgical option in appropriately selected patients without barrett¿s esophagus or a large hiatal hernia in order to avoid unnecessary dissection and preserve the patient¿s native gastric anatomy.Msad is an important treatment option and will expand the surgeon¿s role in treating gerd.

• Brand Name: UNK LINX MAGNETIC IMPLANT
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• Manufacturer Contact: milt garrett ; 4188 lexington avenue north; shoreview, MN
• MDR Report Key: 9081487
• MDR Text Key: 161098163
• Report Number: 3008766073-2019-00457
• Device Sequence Number: 1
• Product Code: LEI
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: P100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/23/2019

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 Catalogue Number: UNK LINX MAGNETIC IMPLANT
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/23/2019
• Initial Date FDA Received: 09/18/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1