The Nature and Pattern of Coronary Stent Recalls

Abstract: Background. Each year, over 1 million percutaneous coronary interventions (PCIs) are performed in the United States. Coronary stents have been shown to reduce restenosis or abrupt vessel closure and therefore have improved the success of PCI. Rarely, manufacturers recall stents due to unanticipated problems. We sought to study the extent and pattern of stent recall. Objective. To determine the number and rate of stent recall and safety alerts, to identify trends in the rates, and to identify the nature of stent recalls. Sources. The Food and Drug Administration (FDA; https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm) and Healthcare Recall Management websites (RASMAS; https://alerts.rasmas.noblis.org/rasmas/c/selectViewAlertList.do) were searched. The search terms for recall were, “coronary stent” or “stent.” Study period. Dates were searched between November 2002 and June 2013. Results. There were 17 coronary stent recalls involving almost 500,000 units; 12 recalls (71%) were before 2006 and 5 recalls (29%) were after. Thirteen recalls (76%) consisted of class II recalls (moderate hazard); the remaining 4 were equally split between class I (severe hazard) and class III (mild hazard; 12% each). The common reasons for recall were concerns with sterility (29%) followed by wrong labeling/packaging (23%) and impaired delivery of stent (18%). In terms of units involved with recalls, 98% (472,189/481,131) were related to wrong labeling/packaging or misbranding, while 0.1% (542/481,131) were related to potential for broken struts or crack in inflation port hub or sterility. However, approximately 2% of units were related to the potentially lethal problem of impaired balloon inflation. Recalls involved multiple manufacturers with various stent types. Conclusion. The overall incidence of coronary stent recall is low and has declined over the years. The majority of stent recalls are of moderate hazard. However, due to the possibility of serious injury, clinicians should be aware of recalls.

J INVASIVE CARDIOL 2014;26(9):433-436

Key words:  stent recalls, coronary stent, device recalls

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Since the introduction of the stent by Puel and Sigwart in 1986, stent use has increased significantly in the management of coronary artery disease (CAD).¹ By 1999, more than 84% of percutaneous coronary interventions (PCIs) included stent implantation.² Each year, over 1 million PCIs are performed in the United States (US). With its widespread use, defects or errors of manufacturing have been apparent over the years. These unforeseen problems can sometimes lead to a product recall. In the US, the Food and Drug Administration (FDA) is responsible for the safety and oversight of all medical devices including coronary stents. The FDA works with the manufacturers to publish press releases and other public notices about recalls that may potentially present a significant risk to the consumers or users of the product. The reports may include safety alerts (advisories) or recalls. The recalls can be divided into three types based on the level of hazard (Table 1). Product and safety alerts are also issued by healthcare product and device manufacturers, distributors and wholesalers, and government agencies other than FDA (ie, consumer product safety commission). These alerts lack consistency in terminology and format as well as timeliness in reaching to the concerned parties (manufacturer, distributors, health-care providers, patients, etc). Healthcare Recall Management (RASMAS) is a web-based subscription service that provides notification, distribution, and management of product alerts and recalls for all health-care and consumer products used in health-care facilities. 

Defective coronary stents can be dangerous and may lead to surgery or death.³ Despite resources like the FDA and RASMAS, the nature and rates of stent recalls have not been reported. Therefore, we studied the FDA and RASMAS databases for coronary stent recalls.

Methods

Two websites were searched for recalls: (FDA [https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm] and RASMAS [https://alerts.rasmas.noblis.org/rasmas/c/selectViewAlertList.do]). Search terms used in the study were either “coronary stent” or “stent.” Search dates were between November 2002 and June 2013. 

In the FDA database, classified medical device recalls were listed since November 1, 2002. A total of 528 items were found with the following search items: product name (stent), recall class (1 to 3), sort by (date record posted-descending). With “coronary stent” as a search term, a total of 14 items were found. 

In the RASMAS database, the earliest entry went as far back as September 2, 2003. A total of 163 items were found with the following filters: show (all), domain (all), sort by: (release date-descending), search (stent). With search term “coronary stent,” 17 items were found. We went over the recall descriptions. Most referred to other stent types (ie, biliary stent, peripheral stent, etc). We focused on coronary stents (excluding angioplasty balloon) and found 17 cases of recall after combining the FDA and RASMAS search results. Frequency and trend graphs were prepared by SPSS statistics (version 17.0; release date, Dec 1, 2008). 

Results

Number, types, and rates of recalls. There were 17 stent recalls during the study period, affecting 481,131 stents. The incidence of recalls varied from 0 in the years 2006 and 2012, to 8 in 2003. Twelve recalls (71%) recalls were before 2006, and 5 recalls (29%) were after 2006. The incidence of recalls has declined, from 8 in 2003 to 1 in 2011 (Figure 1).

Of the 17 recalls, class II recalls were the most common, consisting of 13 of all recalls (76%) (Figure 2). Class I and class III recalls were at 2 each (12%). Type II recalls mean that the product might cause a temporary health problem, or pose only a slight threat of a serious nature. Class I recalls are the most serious in nature. Two of these recalls were made in 2004 and involved the Boston Scientific Corporation. The company announced the recalls of Taxus Express2 paclitaxel-eluting coronary stent system and Express2 bare-metal stent system. The recall was due to characteristics in the delivery catheters that had the potential to impede balloon deflation during a coronary angioplasty procedure. The Boston Scientific Corporation had received reports of 1 death and 18 serious injuries associated with balloon deflation for the TAXUS stent system, and 2 deaths and 25 serious injuries associated with balloon deflation in the Express2 bare-metal stent system.⁴ 

Recalls affected many companies and included a variety of stents. In addition to Boston Scientific Corporation, Medtronic Vascular Galway Limited, Abbott Vascular-Cardiac Therapies, Guidant Corporation, Cordis Corporation, Boston Scientific Scimed, and Abbott Vascular Devices have been implicated. Both drug-eluting (paclitaxel, sirolimus, or zotarolimus) and bare-metal stents have been recalled. 

Two out of 17 recalls did not provide the number of units recalled. In the remaining cases, recalls involved 481,131 units (Table 2). Almost 472,000 units (98%) were recalled due to reasons such as incorrect labeling, incorrect packaging, or misbranding (wrong expiration date) of the device. In terms of reason for recalls during the study period, “concerns with sterility” was the most common, accounting for 5 (29%) of all recalls over the last 10 years. Other reasons for recall included “impaired delivery of stent” (3; 18%) or “potential for broken struts/reduced polymer/crack in inflation port hub” (3; 18%). In terms of approximate number of units affected by recall, class II was the largest (400,334; 83%) followed by class III (80,397; 16.9%) and class I (400; 0.1%).

Coronary stents are expensive items. Drug-eluting stents cost more than bare-metal stents. One 2006 study⁵ that analyzed the economic impact of stents suggested that many US centers paid roughly $2200 for a DES, while an average acquisition cost for a BMS was $600. Considering the average cost of a stent at $1700.00 (assuming 70% of stents as DES and 30% as BMS), the annual loss of a company could be in the order of approximately $82,000,000 (48,113 [total units divided by 10 for total number of years] multiplied by $1700). 

Discussion

Over the last 10 years, a total of 17 coronary stent recalls have been made. As such, the stent recall is infrequent considering the thousands of medical device recalls in the FDA or RASMAS databases. Additionally, there has been a decline in the number of recalls over the years. The majority of the recalls were of class II, suggesting that the risk to the consumer was only moderate or possibly could cause temporary health problems. Stent recall is a serious issue for a number of reasons. First, stents are implanted frequently, resulting in a substantial population exposure. It has been estimated that more than 1 million PCIs are performed in the US.⁶ Second, when a defective stent has been deployed, there is no practical way to remove it. Therefore, patients would continue to be at risk for stent complications (thrombosis, in-stent restenosis, etc). Fortunately, the majority of recalls were related to the production, manufacturing, and distribution, allowing units to be removed from inventory prior to patient exposure. 

There are economic implications to stent recall. PCI is common in the US, and the overall annual PCI rate has remained steady over several years (approximately 3900 PCIs per million adults per year).⁶ Additional costs may be generated by patient morbidity and mortality, malpractice lawsuits, additional hospital days, revascularization costs, and reduction of stock prices. 

Most importantly, the stent recall relates to patient safety. When an FDA-regulated product is either defective or potentially harmful, recalling that product, removing it from the market or correcting the problem, is the most effective means to protect the public. However, the latency between a notification to the FDA and the FDA action of calling a recall is variable and unpredictable. The FDA issued a class 1 recall of Express2 bare-metal stent system and Taxus Express2 paclitaxel-eluting stent in July 2004 based on multiple reports of serious injuries and stent malfunctions. Of note, there was a long period between notifications to the FDA and the FDA’s action. The MAUDE (Manufacturer and User friendly Device Experience) database contains reports of medical devices that have malfunctioned or caused deaths. These data consist of all voluntary reports from user facilities, distributors, and manufacturers. While reviewing the database, it appears that in the case of the above two coronary stent systems, almost 500 reports were available before the FDA announced the class 1 recall. For the Express2 bare-metal stent, the first report was logged in October 2002 (21 months prior to recall), which was followed by hundreds of intermittent but sustained reports. Some of the complaints included difficulty crossing the lesion, kinking and fracture of the hypotube, stent getting stuck in the lesion, balloon not inflating or deflating properly, incomplete expansion, and premature deployment. The FDA imposed a class 1 recall based on 2 deaths and 25 serious injuries related to the stent system. The reason for the recall provided by the manufacture was “due to characteristics in the delivery catheters that have the potential to impede balloon deflation during a coronary angioplasty procedure.” 

In the case of the Taxus Express2 paclitaxel-eluting stent, the first report was in April 2003 (15 months prior to recall) suggestive of subacute thrombosis. Again, the first report was followed by hundreds of reports of various nature. Some of the complaints included stent dislodgment, device malfunction, flaring of stent, breaking of delivery system, hypotube fracture, difficulty crossing, and stent getting stuck to the previous stent. The FDA instituted a class 1 recall based on 1 death and 18 serious injuries related to the stent system. The reason for the recall provided by the manufacturer was “on a few occasions, the balloon has failed to deflate within 1 minute after deployment of the stent.”

The entries in the MAUDE database also mention the responses from the manufacturers. They have tried to evaluate the stent and delivery system (if available) for specific issues that might explain malfunction. If the stent is returned for analysis, they have described the gross and microscopic appearances. The shop floor paperwork for the batch is also reviewed for issues or discrepancies related to the material, assembly, and performance specifications. 

Readers are encouraged to view the MAUDE database in the FDA website for specific details of the cases of stent malfunction or injuries.

Study limitations. This is a retrospective study of data presented by the FDA and RASMAS. The primary data provided by the manufacturer have not been reviewed; therefore, completeness of the data is uncertain. 

Conclusion

In summary, the overall incidence of coronary stent recall is low. The incidence of recall has diminished over the years. In one-third of cases, recalls are related to sterility of packaging. In terms of units recalled, the majority were due to wrong packaging or labeling of stents. However, due to possibility of serious harm to the patients, clinician should be aware of recalls.

References

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2. Holmes DR Jr, Savage M, LaBlanche JM, et al. Results of Prevention of REStenosis with Tranilast and its Outcomes (PRESTO) trial. Circulation. 2002;106(10):1243-1250.
3. FDA Announces Recall of Express 2 Coronary Stent System [database on the Internet]. 2004 [accessed 06/06/2013]. Available at https://www.medscape.com/viewarticle/484162.
4. Not For The Faint Of Heart Boston Scientific’s stent recall is a blow to earnings--but an opportunity for investors. [database on the Internet]. CNN Money. 4004 [cited June 6, 2013]. Available at https://money.cnn.com/magazines/fortune/fortune_archive/2004/08/09/377913/.
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6. Epstein AJ, Polsky D, Yang F, Yang L, Groeneveld PW. Coronary revascularization trends in the United States, 2001-2008: JAMA. 2011;305(17):1769-1776.

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From the Division of Cardiovascular Medicine, SUNY Downstate Medical Center, Brooklyn, New York. Dr Kumar’s current affiliation is Marshfield Clinic-Weston Center, Weston, Wisconsin.

Disclosure: The authors have completed and returned the ICMJE Form for Disclosure of Potential Conflicts of Interest. The authors report no conflicts of interest regarding the content herein.

Manuscript submitted November 11, 2013, provisional acceptance given November 26, 2013, final version accepted March 7, 2014.

Address for correspondence: Jonathan D. Marmur, MD, FRCP(c), FACP, FACC, Director, Cardiac Catheterization and Interventional Cardiology, SUNY Downstate Medical Center, 450 Clarkson Avenue, Box 1257, Brooklyn, NY 11203-2098. Email: jmarmur@gmail.com