eMedinews

Abbott Coronary stents account for more than half of the adverse event reports in 2018 for medical devices as per an Indian Express report. An analysis by the Indian Pharmacopoeia Commission shows they have received 290 adverse reports — of 556 reports logged so far this year — for devices manufactured by Abbott, and a vast majority are for its top selling Xience Prime, Xience Xpedition and Xience Alpine drug-eluting coronary stents.

1. July 23, 2018 at the Saraswati Heart Care Hospital in Allahabad. The report states an Abbott Xience Xpedition stent was implanted on a heavily calcified LAD (left anterior descending coronary artery). Subsequently, dissection was noted, and another Xience Expedition stent was implanted. However, the patient expired. The cause of death was not provided by the hospital.
2. January 5, 2018 at the Holy Heart Advanced Cardiac Care & Research Center, Rohtak. The report states that a drug-eluting Xience Alpine Abbott stent was implanted on a patient, who had suffered a myocardial infarction (heart attack), with good results. About 30-40 minutes, post implantation, the patient experienced chest discomfort and an angiography showed thrombosis. Therefore, another Xience Alpine stent was deployed across the previously implanted stent to treat the thrombosis.
3. June 23, 2018 (name of hospital not given in report). An Abbott Xience Xpedition Stent Delivery System (SDS) was advanced in the LAD (left anterior descending) coronary artery of a 62-year old male patient and the stent implanted. Subsequently, a dissection was noted in the left main coronary artery and another Xience Xpedition stent was implanted to treat the dissection. But, the patient expired.
4. In case after case, there is mention of dissection and, in a few cases, stent thrombosis being noticed but the conclusion in the reports varies from the “adverse event” either being caused or not caused by the device or that the investigation in the case was incomplete/the cause of death not provided.
5. In 13 cases of death in the 2018 reports, there is only one linked to a drug-eluting stent not manufactured by Abbott. And there is only one among the 12 cases reported for Abbott devices where there is a description that the patient took discharge from hospital against medical advice and passed away.

Almost 300 such adverse events have been reported this year connected to devices manufactured by one company. The medical profession needs an answer to the findings. What should we advise our patients? We need an urgent statement from Cardiological Society of India about the safety of these stents.

Excerpts from Abbott Response

On Do not rely on “sensational” journalism.

XIENCE family of products is recognized as the gold-standard drug eluting stents for the treatment of coronary artery disease. The XIENCE family of drug eluting stents are among the world’s most used and studied stents and have an exceptional safety record based on 10 years of global real-world experience and over 100 clinical trials, with 100000+ patients across various disease subsets. 

In India, XIENCE has been the stent of choice for over 12 years and has been implanted in ~12 Lakh patients, as it remains preferred choice of clinicians due to its safety and efficacy parameters. The XIENCE family has also been studied extensively on Indian patients through “Xience V India” and other trials.

So called adverse events reported in the article could not just be product performance but also an outcome of patient comorbidities, general patient condition, procedure skills and other complications. Also, some common adverse reactions, just like any other drug are a part of any device IFU and at times may not even be related to the product.

India uses close to 500,000 stents each year with close to 50 DES brands. From that perspective, the #556 reported seems ambiguous and misleading and leads to a more important question of how many companies are actually in compliance with the reporting requirements of CDSCO. We are unaware of the reporting done by other companies but there should be a follow up on that aspect to gain an accurate understanding of the situation.

These complaints were submitted by Abbott voluntarily to regulators as per the compliance requirement , the number #290 is also misleading as it might not be unique events but could be 2-3 reports of a similar event, these events contribute to less than 0.1% of the total stents Abbott sells in a year (Abbott sells roughly 200000 stents per year).