At least three people have died from complications related to a surgically implacted tissue reinforcement products sold by medical device maker Covidien under the brand name Duet TRS.
The Covidien Duet TRS, launched in 2009, is system the company sold to surgeons for inserting a material to support surgical staples in chest surgeries (thoracic surgeries). The Duet TRS is a single-use cartridge, which contains a material that is applied along with staples. Covidien marketing materials say “[t]he Duet TRS™ reinforcement material is a synthetic absorbable film prepared from synthetic polyester composed of glycolide, dioxanone, and trimethylene carbonate.”
The company also admitted to knowing of at least 13 serious injuries linked to the Covidien Duet TRS tissue reinforcement product, in addition to the three deaths.
Covidien released a statement saying “The company has concluded that Duet TRS has the potential to injure adjacent anatomical structures within the thorax, which may result in life-threatening, post-operative complications.”
The company maerkets the product as “A whole new approach to tissue reinforcement.” Now, after disclosing the product-related deaths and injuries, the company is telling doctors the product should never be used in chest surgery — the exact use the company had been promoting for years.
Covidien is a global corporation with dozens of offices, manufacturing sites and distribution sites in the United States, as well as locations in numerous other countries.
The affected product codes and descriptions are as follows:
DUET4535 DUET TRS 45 3.5MM STRAIGHT SULU DUET4535A DUET TRS 45 3.5MM ARTICULATING SULU DUET4548 DUET TRS 45 4.8MM STRAIGHT SULU DUET4548A DUET TRS 45 4.8MM ARTICULATING SULU DUET6035 DUET TRS 60 3.5MM STRAIGHT SULU DUET6035A DUET TRS 60 3.5MM ARTICULATING SULU DUET6048 DUET TRS 60 4.8MM STRAIGHT SULU DUET6048A DUET TRS 60 4.8MM ARTICULATING SULU
The attorneys at Aylstock, Witkin, Kreis & Overholtz are investigating the extent of this problem and the impact to patients, to enforce victims’ rights and to pursue all appropriate actions against the manufacturer.