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Complications with the product surfaced when surgeons attempted
to replace the stent graft. Once placed, surgeons had problems removing
the delivery system for the device. The catheter used to replace
the implant would become lodged in the patient and often the surgeon
would have to literally break the handle from the catheter in order
to remove it from the patient's body. In some cases, it is reported
that a Guidant salesperson with no medical training, would talk
the surgeon through an emergency removal procedure of the product.
Many of these emergency removals were unsuccessful and emergency
open-abdominal or open-heart surgery resulted. 12 deaths have been
reported from the malfunction of the Guidant Ancure stent graft.
Approximately 18,000 people received the implants.
Though these malfunctions were supposed to be reported to the FDA, they were covered up. More than 2,600 incidences of Guidant Ancure stent graft malfunctions were not filed. The FDA caught wind of the massive problem when an anonymous group of Guidant employees sent the FDA a letter announcing their concerns regarding the defective and potentially fatal system. The product's sales were briefly suspended and then it was put back on the market with instructions on how to remove the catheter should it become lodged in a patient's body.
Later, federal charges were brought against the company that produced the Guidant Ancure stent graft. The company pleaded guilty to charges that they covered up serious malfunctions with their Ancure stent graft system. Sales of the product were halted in October, 2001.
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