BI 108- Spring 2007	Major Recalls of Organ Replacement Devices
HOME Recall Information Baxter Dialyzer Bjork-Shiley Heart Valve Guidant AAA Stent Guidant ICD Saint Gobain Desmarquest Hip Implant Sulzer Hip Implant Conclusions Brown University BI 108 Website CONTACT	Guidant Ancure AAA Stent Recall Introduction In June 2003, Endovascular Technologies pled guilty to ten felony counts for failure to report essential data regarding device failures to the FDA. They were ordered to pay damages in excess of $90 million, to date the largest penalty ever levied against a medical device manufacturer for such a crime [1]. The settlement concerned failures in the Ancure stent system, used to repair abdominal aortic aneurysms. The device’s delivery system failed in over 30% of surgical procedures, and contributed to no less than 12 deaths during an approximately 18 month period between FDA approval and formal recall. Return to top Application Endovascular technologies, Inc. (EVT), a subsidiary of Guidant Corp., originally developed the Ancure stent system as a less invasive means to repair abdominal aortic aneurysms (AAA’s). A AAA is a weakening of the aortic wall that often presents as a bulge in the vessel wall, as seen in figure 1 below. Left unchecked, AAA’s can rupture, causing a Figure 1: A typical AAA, exhibiting significant distension of the aortic wall [2] substantial loss of blood that is fatal in the vast majority of cases. For those desiring further information, a good summary of AAA’s can be found at www.vascularweb.org. Normally, the condition is repaired by opening the patient’s abdomen and surgically revising the affected region. Approved by the FDA for commercial sale on September 30, 1999 [3], the Ancure system was designed to function as a conduit, taking up the outward forces of arterial pressure normally exerted on the endothelium. It was implanted in much the same way as coronary artery stents (only on a much larger scale – the stent’s final diameter was approximately 28mm and came at a cost of about $10,000 Figure 2: Guidant Ancure aortic stent [5] USD [4]), inserted into the femoral artery via an incision in the groin, and threaded to its final position using a catheter then expanded using a high pressure balloon. In so doing, it was hoped that the stent system would reduce pressure on the aneurysm, significantly decreasing the probability of rupture. While this was excellent in theory, the stent system was subject to several complications in the clinical setting. Return to top Device Failure The most significant and commonly experienced complication did not directly involve the stent itself, but rather the catheter used to move the stent into position and expand it to its final size. In many cases, the catheter would become lodged within the patient after implantation of the stent, and could not be removed by conventional means. Often, this complication required that the patient undergo an emergency operation to remove the stent and repair the aorta by conventional means. EVT became aware of this malfunction shortly after FDA approval of the device, but continued to actively market it for some time. Doctors were often advised by sales representatives of EVT present in the surgical suite to perform the “handle breaking technique”, where the handle of the delivery system was broken off, and the catheter removed piece by piece. Figure 3: Guidant Ancure delivery system [6] Clinical use of this technique was unacceptable: it had not been evaluated by the FDA, nor had doctors been appropriately trained to perform it. Inevitably it led to the death of several patients, particularly one in January of 2000 that caused a group of Guidant employees to openly question management tactics at the corporation. Return to top Recall While this was clearly unethical, Guidant’s actions became criminal when they failed to report device failures to the FDA. When any medical device manufacturer becomes aware that its product “may have caused or contributed to a death or serious injury; or had malfunctioned and the device would be likely to cause or contribute to a death or serious injury if the malfunction were to recur”, they are required by law to submit a medical device report (MDR) to the FDA. Before the Ancure system was formally recalled in March 2001, EVT submitted 172 MDR’s. In fact, close to 3000 incidents had occurred at that time which could be considered worthy of an MDR. Guidant only chose to disclose the true figures after a group of employees known as the “Anonymous Seven” wrote a letter to the FDA informing them of various questionable practices at EVT, including insufficient testing and reporting of the “handle breaking technique”, as well as failure to report numerous MDR’s. Following a period of intense scrutiny by the FDA, EVT disclosed 2,628 previously unreported MDR’s pertaining to the delivery system, among which were “12 deaths and 57 conversions to traditional open surgical repair”. The most startling aspect of this revelation was the frequency of device failure – only 7,632 devices had actually been shipped at the time, translating to a failure rate over 34%, and a mortality rate of approximately 1 in 500 patients. Interestingly, this is far lower than the mortality rate for surgical AAA repair, averaging about 3.5% [7]. Return to top Resolutions In June 2003, EVT pled guilty to ten felony counts: nine for shipping mislabeled devices (since the “handle breaking technique” was not included among the FDA approved set of device instructions), and one for intentionally withholding information from the FDA. The corporation agreed to pay $43.4 million in criminal penalties, the largest settlement ever recorded against a medical device manufacturer for withholding information. Additionally, EVT reached a civil settlement of $49 million, for a total judgment of $92.4 million. The delivery system was modified under close FDA supervision, and reintroduced into the market in August of 2001, but was pulled again in June 2003. Since the Ancure disaster, the FDA has done little to change the way it monitors MDR reporting. Although the substantial financial penalties levied against Guidant should serve as fair warning to manufacturers engaging in questionable practices, the government has failed to implement new programs that would help prevent future cover-up scandals as well as increase corporate accountability. Return to top References [1] USDOJ Press Release, 12 June 2003. Available http://www.usdoj.gov/usao/can/press/2003/2003_06_12_endovascular.html [2] Vascular Surgery at Uppsala University. Available http://www.medfarm.uu.se/forskning/program.php?vetenskapsid=2&forskomr=63&id=342&lang=en [3] L Bren. Investigators’ Reports: Company Caught in Coverup of Medical Device Malfunctions. FDA Consumer Magazine, November 2003. [4] Plea Agreement, United States of America vs. Endovascular Technologies Inc. Filed 16 June 2003. Available http://www.usdoj.gov/usao/can/press/assets/applets/2003_06_12_Endovascular_inf.pdf [5] AAA Stents: Current developments. Available http://www.medscape.com/viewarticle/407496_6 [6] AncureTM Endograft System. Available http://www.idsa.org/idea/idea2002/S8044.htm [7] AS Brett. Perioperative Mortality With AAA Repair. Journal Watch General Medicine. 7 January 2000. Return to top Last Updated: April 30, 2007

BI 108- Spring 2007

Major Recalls of Organ Replacement Devices

HOME

Recall Information

Baxter Dialyzer

Bjork-Shiley Heart Valve

Guidant AAA Stent

Guidant ICD

Saint Gobain Desmarquest Hip Implant

Guidant Ancure AAA Stent Recall

Introduction

In June 2003, Endovascular Technologies pled guilty to ten felony counts for failure to report essential data regarding device failures to the FDA. They were ordered to pay damages in excess of $90 million, to date the largest penalty ever levied against a medical device manufacturer for such a crime [1]. The settlement concerned failures in the Ancure stent system, used to repair abdominal aortic aneurysms. The device’s delivery system failed in over 30% of surgical procedures, and contributed to no less than 12 deaths during an approximately 18 month period between FDA approval and formal recall.

Return to top

Application

Endovascular technologies, Inc. (EVT), a subsidiary of Guidant Corp., originally developed the Ancure stent system as a less invasive means to repair abdominal aortic aneurysms (AAA’s). A AAA is a weakening of the aortic wall that often presents as a bulge in the vessel wall, as seen in figure 1 below. Left unchecked, AAA’s can rupture, causing a

Figure 1: A typical AAA, exhibiting significant distension of the aortic wall [2]

substantial loss of blood that is fatal in the vast majority of cases. For those desiring further information, a good summary of AAA’s can be found at www.vascularweb.org. Normally, the condition is repaired by opening the patient’s abdomen and surgically revising the affected region. Approved by the FDA for commercial sale on September 30, 1999 [3], the Ancure system was designed to function as a conduit, taking up the outward forces of arterial pressure normally exerted on the endothelium. It was implanted in much the same way as coronary artery stents (only on a much larger scale – the stent’s final diameter was approximately 28mm and came at a cost of about $10,000

Figure 2: Guidant Ancure aortic stent [5]

USD [4]), inserted into the femoral artery via an incision in the groin, and threaded to its final position using a catheter then expanded using a high pressure balloon. In so doing, it was hoped that the stent system would reduce pressure on the aneurysm, significantly decreasing the probability of rupture. While this was excellent in theory, the stent system was subject to several complications in the clinical setting.
Return to top

Device Failure

The most significant and commonly experienced complication did not directly involve the stent itself, but rather the catheter used to move the stent into position and expand it to its final size. In many cases, the catheter would become lodged within the patient after implantation of the stent, and could not be removed by conventional means. Often, this complication required that the patient undergo an emergency operation to remove the stent and repair the aorta by conventional means. EVT became aware of this malfunction shortly after FDA approval of the device, but continued to actively market it for some time. Doctors were often advised by sales representatives of EVT present in the surgical suite to perform the “handle breaking technique”, where the handle of the delivery system was broken off, and the catheter removed piece by piece.

Figure 3: Guidant Ancure delivery system [6]

Clinical use of this technique was unacceptable: it had not been evaluated by the FDA, nor had doctors been appropriately trained to perform it. Inevitably it led to the death of several patients, particularly one in January of 2000 that caused a group of Guidant employees to openly question management tactics at the corporation.

Return to top

Recall

While this was clearly unethical, Guidant’s actions became criminal when they failed to report device failures to the FDA. When any medical device manufacturer becomes aware that its product “may have caused or contributed to a death or serious injury; or had malfunctioned and the device would be likely to cause or contribute to a death or serious injury if the malfunction were to recur”, they are required by law to submit a medical device report (MDR) to the FDA. Before the Ancure system was formally recalled in March 2001, EVT submitted 172 MDR’s. In fact, close to 3000 incidents had occurred at that time which could be considered worthy of an MDR. Guidant only chose to disclose the true figures after a group of employees known as the “Anonymous Seven” wrote a letter to the FDA informing them of various questionable practices at EVT, including insufficient testing and reporting of the “handle breaking technique”, as well as failure to report numerous MDR’s. Following a period of intense scrutiny by the FDA, EVT disclosed 2,628 previously unreported MDR’s pertaining to the delivery system, among which were “12 deaths and 57 conversions to traditional open surgical repair”. The most startling aspect of this revelation was the frequency of device failure – only 7,632 devices had actually been shipped at the time, translating to a failure rate over 34%, and a mortality rate of approximately 1 in 500 patients. Interestingly, this is far lower than the mortality rate for surgical AAA repair, averaging about 3.5% [7].
Return to top

Resolutions

In June 2003, EVT pled guilty to ten felony counts: nine for shipping mislabeled devices (since the “handle breaking technique” was not included among the FDA approved set of device instructions), and one for intentionally withholding information from the FDA. The corporation agreed to pay $43.4 million in criminal penalties, the largest settlement ever recorded against a medical device manufacturer for withholding information. Additionally, EVT reached a civil settlement of $49 million, for a total judgment of $92.4 million. The delivery system was modified under close FDA supervision, and reintroduced into the market in August of 2001, but was pulled again in June 2003. Since the Ancure disaster, the FDA has done little to change the way it monitors MDR reporting. Although the substantial financial penalties levied against Guidant should serve as fair warning to manufacturers engaging in questionable practices, the government has failed to implement new programs that would help prevent future cover-up scandals as well as increase corporate accountability.

Return to top

References

[1] USDOJ Press Release, 12 June 2003. Available http://www.usdoj.gov/usao/can/press/2003/2003_06_12_endovascular.html

[2] Vascular Surgery at Uppsala University. Available http://www.medfarm.uu.se/forskning/program.php?vetenskapsid=2&forskomr=63&id=342&lang=en

[3] L Bren. Investigators’ Reports: Company Caught in Coverup of Medical Device Malfunctions. FDA Consumer Magazine, November 2003.

[4] Plea Agreement, United States of America vs. Endovascular Technologies Inc. Filed 16 June 2003. Available http://www.usdoj.gov/usao/can/press/assets/applets/2003_06_12_Endovascular_inf.pdf

[5] AAA Stents: Current developments. Available http://www.medscape.com/viewarticle/407496_6

[6] AncureTM Endograft System. Available http://www.idsa.org/idea/idea2002/S8044.htm

[7] AS Brett. Perioperative Mortality With AAA Repair. Journal Watch General Medicine. 7 January 2000.

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Last Updated: April 30, 2007