Updated June 17, 2012, at 3:30 p.m. with comment from Covidien.
The FDA wants Covidien (NYSE:COV) to defend its management of the recall of its Duet TRS surgical staples, which were pulled off the shelves after they were implicated in 13 patients injuries and 3 deaths.
The FDA chided the device maker for its lack of sufficient documentation and delayed response to adverse event reports associated with the Duet device, which were first noted more than 2 year prior to the recall.
"Despite receiving numerous complaint, adverse event, and serious adverse event information since May of 2009 regarding use of the Duet TRS, a [corrective and preventative action] investigation was not initiated until January 19, 2012," according to the FDA warning letter.
"Covidien is working to address the FDA’s concerns related to our North Haven, Connecticut facility and the Duet TRS product manufactured there," a company spokesperson told MassDevice.com today. "We will respond to the FDA within the specified timeframe and address these issues in a timely manner."
Covidien issued warnings in January 2012 contraindicating its Duet TRS single-use heads for use in thoracic surgery after determining 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 noted at the time that it was working with the FDA and other worldwide regulatory bodies to modify the product’s instructions and warn against using Duet TRS in thoracic procedures. The Mansfield, Mass.-based device maker also placed a hold on its global Duet TRS inventory to conduct relabeling.
FDA inspectors conducted an investigation of Covidien’s North Haven, Conn., facility between Jan. 13 and Feb. 9, concluding that the company "failed to document investigations into deaths and serious injuries" that spurred the safety warnings for the Duet TRS devices 1st issued in Japan in March 2011.
The agency also concluded that the facility’s manufacturing, storage, packaging and installation methods were "not in conformity with the current good manufacturing practice requirements."
Covidien responded to the agency’s concerns in February, but inspectors deemed the response inadequate.
"Your firm did not provide a description or evidence of implementation of a correction or corrective action, including retrospective review of complaints to ensure that documented corrective actions were implemented, for the complaints received for abdominal indications of use for similar patient injuries/deaths," according to the warning letter.