Wednesday, June 27, 2012

Covidien Recall Duet TRS units

The U.S. Food and Drug Administration said the company had received numerous complaints related to the use of the product since May 2009.

Covidien, however, did not initiate a corrective and preventative action until later in January of 2012. It was that month when an  FDA inspection team sought to review data related to the complaints, the regulator said in a warning letter.


Here's the letter from June 14:

-

Covidien LP 6/14/12



  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 
New England District
One Montvale Avenue
Stoneham, Massachusetts 02180
Phone: (781) 587-7500
FAX: (781) 587-7556 
WARNING LETTER
CMS#282277
VIA UPS
June 14, 2012
 
Mr. Jose E. Almeida
President and CEO
Covidien, Inc.
15 Hampshire Street
Mansfield, Massachusetts 02048 
Dear Mr. Almeida,
During an inspection of Covidien, LP, located in North Haven, Connecticut, on January 13, 2012, through February 09, 2012, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures surgical staples and single-use loading units, such as the DUET Tissue Reinforcement System (TRS) Reload (Staple, Implantable). Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.
This inspection revealed that these devices are adulterated within the meaning of section 501 (h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.
We received a response from Mr. Garrett B. Raymond, Vice President Global Quality Assurance and Regulatory, dated February 24, 2012, concerning our investigators' observations noted on the Form FDA 483 (FDA 483) List of inspectional Observations that was issued to your firm. We address this response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:
 
1. Failure to implement your firm's procedures for implementing corrective and preventive actions, as required by 21 CFR 820.100(a). Specifically, your firm failed to initiate a corrective and preventative action (CAPA) after the review of quality data based on trend, criticality, recurrence, and correlation obtained from complaints and adverse events to ensure the proper course of action would be undertaken as described in your firm's procedure, (b)(4). Despite receiving numerous complaint, adverse event, and serious adverse event information since May of 2009 regarding use of the DUET TRS, a CAPA investigation was not initiated until January 19, 2012 and after the FDA inspection team requested to review the CAPA file related to these complaints and adverse events.
 
The response dated February 24, 2012, is not adequate.

Here's the letter from earlier in the year:

January 16, 2012 -Covidien (NYSE: COV), a leading global provider of healthcare products, today announced that it is conducting a voluntary recall of all production lots for the Duet TRS Universal Straight and Articulating Single Use Loading Units, with respect to the use of this product family in the thoracic cavity.

“After receiving reports connecting the use of the Duet TRS with patient deaths after thoracic surgery, we have made the decision that the product should not be used in such procedures,” said Bryan Hanson, Group President, Surgical Solutions, Covidien. “Accordingly, we are advising our customers that the Duet TRS should not be used in thoracic surgery.”

Covidien has received reports of 13 serious injuries and three fatalities, following the application of Duet TRS in the thoracic cavity. 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 affected product codes and descriptions are as follows:
DUET4535
DUET4535A
DUET4548
DUET4548A
DUET6035
DUET6035A
DUET6048
DUET6048A
DUET TRS 45 3.5MM STRAIGHT SULU
DUET TRS 45 3.5MM ARTICULATING SULU
DUET TRS 45 4.8MM STRAIGHT SULU
DUET TRS 45 4.8MM ARTICULATING SULU
DUET TRS 60 3.5MM STRAIGHT SULU
DUET TRS 60 3.5MM ARTICULATING SULU
DUET TRS 60 4.8MM STRAIGHT SULU
DUET TRS 60 4.8MM ARTICULATING SULU






Covidien is working with the United States Food and Drug Administration (FDA) and other worldwide regulatory authorities to modify instructions for use to contraindicate the device in thoracic procedures in both adult and pediatric populations. Further, the Company placed a hold on its Duet TRS inventory globally to allow for the relabeling with new instructions for use.  Additionally, it is providing information to its customers on alternative tissue reinforcement products that may be used in conjunction with Covidien endoscopic staplers for thoracic surgery.

“These steps are consistent with our belief that patient safety is a commitment that cannot be compromised,” said Hanson.  “Patient safety is our first obligation.”

Launched in 2009, the Duet TRS is a single-use loading unit with a fully integrated tissue reinforcement system to support staple lines in tissues. To date, the Company has sold more than 500,000 units worldwide. Covidien believes approximately one-third of global procedures using Duet TRS are for thoracic indications.  The Duet TRS will continue to be used for other indications, including abdominal procedures. 


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