Events

Safety Alert for ANCURE ENDOGRAFT - endovascular prosthesis used in the treatment of abdominal aortic aneurysm.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by GUIDANT DO BRASIL LTDA.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    723
  • Date
    2003-07-23
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
  • Extra notes in the data
    The company also informs that patients who have currently implanted the product ANCURE ENDOGRAFT, do not run any type of risk, because the observed events occurred at the time of implantation. In reference to the news circulated in the local press, it is true that Guidant made all these mistakes, however, we clarified that the $ 94 million compensation that Guidant Corporation will pay to some patients is a result of the decision of the Court of Justice of the United States of America and corresponds to actions against the company for marketing the ANCURE ENDOGRAFT product with that old labeling material that does not comply with FDA regulations. Although the product has shown a very satisfactory performance in the treatment of abdominal aortic aneurysm and presents no risk to the patient, the Guidant Corporation has decided to discontinue its commercialization in the face of all the events occurring with the product, but will not fail to watch or follow its directly or indirectly through the medical professionals involved. To do so, Guidant has provided a hotline to clarify the doubts of patients who may be outside the United States, as well as the entire medical class, through the 24-hour number available (1-650-4706422) or by e-mail ancureQuestions @Quidantcom. In Brazil, we also provide our Customer Service lines, during business hours, through the numbers (11) 3841-8390 or 3841-8399. - UNTIL THIS DATE DOES NOT INCLUDE REGISTRATION OF THE PRODUCT IN BRAZIL.
  • Reason
    The ancure endograft product belonged to the us company endovascular technologies inc. which was acquired by the guidant corporation, becoming part of one of the company's business divisions, endovascular solutions, which in addition to products for the treatment of abdominal aortic aneurysm also have a product line for peripheral angioplasty. at the time endovascular technologies inc. was incorporated by guidant, it was found that this company had not reported to the fda a number of incidents with the device, when it should have done it in accordance with its regulations. in march 2001, the guidant corporation decided to withdraw the product from the north american market to remedy all regulatory issues inherited from endovascular technologies inc. to date, 7,700 prostheses had been implanted with 16 death occurrences of 57 incidents in need of re -surgical intervention. the observed mortality rate was within the predicted clinical studies performed with the product, given the precarious state of health of patients who undergo an implantation procedure of a stent, as well as the amount of complications arising from the procedure itself. patients with abdominal aortic aneurysm are generally elderly and severely compromised. the mortality rate in conventional open surgeries is 3 - 5% and involve weeks of convalescence. complications may include, among other events, heart stress and damage to vital nerves. although the mortality rate from implantation of stents using the ancure endograft product is substantially the same, patients suffer fewer complications such as blood loss and heart tension and benefit from a shorter convalescence period. in addition, endovascular technologies inc. also failed to properly comply with the labeling, packaging, and use instructions that came with the product. in this way, guidant corporation management has thoroughly revised all technical and communication procedural issues to ensure that these problems do not recur.
  • Action
    The design of the device was changed in order to improve the delivery system of the prosthesis and thus facilitate its manipulation during the procedure and consequently, all the labeling material and instructions for use of the product were adapted, as well as the promotion of extensive medical class training. Further tests and inspections were conducted by the FDA and in August 2001, Guidant Corporation again regained approval of the ANCURE ENDOGRAFT product. Since then, the company has reported no adverse event or death and all labeling material has fully complied with FDA requirements.

Device

ANCURE ENDOGRAFT - endovascular prosthesis used in the treatment of abdominal aortic aneurysm.

Manufacturer

GUIDANT DO BRASIL LTDA
  • Source
    ANVSANVISA