2003: Guidant Ancure Endograft System 161
Food and Drug Administration, Premarket Application for ANCURE Tube System, ANCURE
Bifurcated System, ANCURE Iliac Balloon Catheter. P990017. September 28, 1999.
http://www.fda.gov/cdrh/pdf/P990017b.pdf.
Jacobs, P., Medical firm’s dangerous secret device’s troubles were well known at Menlo Park
company. SJ Merc News, 1A,August 3, 2003.
Plea Agreement, U.S. v. Endovascular Technologies, Inc., Case No. CR-02-0179 SI, U.S.
District Court (N.D.CA 0612), 2003.
United States Attorney’s Office, Northern District of California, Endovascular Press Release,
June 12, 2003. http://www.usdoj.gov/usao/can/press/html/2003_06_12_endovascular.html.
United States Code, 2004. http://www.straylight.law.cornell.edu/uscode.
QUESTIONS FOR DISCUSSION
1. How should medical device risk be assessed?
2. Hazard analysis refers to the systematic use of available information to
identify potential sources of harm and to estimate the accompanying
risk. Hazard analysis for a medical device is described by Daniel Kamm
in http://www.fmeainfocentre.com/download/risk1.pdf. Construct a haz-
ard analysis for the Ancure Endograft System.
3. What were possible causes of the difference in complication rate during
clinical trials described in the PMA application and after market release?
4. When the Anonymous Seven sent their letter to the FDA, they did not
initially disclose their identities. How would identity disclosure have
altered the federal investigation of EVT and the resulting settlement?
5. In early 2004, the FDA began to implement a new third-party inspection
program. This program addresses the need for more FDA inspectors
because most medical device facilities are not inspected biennially as
required. How would you ensure that device companies are following
FDA regulations?
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