19 Deaths Force Medtronic to Warn Doctors on Heart Valve Delivery System
August 18, 2016
By Alex Keown, BioSpace.com Breaking News Staff
DUBLIN – Nineteen deaths and 20 other vascular trauma events linked to Ireland-based Medtronic ’s EnVeo R replacement heart valve delivery catheter has prompted that company to warn doctors not to “force passage” if the catheter meets resistance, Mass Device reported this morning.
This week, the company issued a letter to physicians saying it will update instructions on installation of the EnVeo system, which is used to treat the narrowing of the heat valve. The Minneapolis Star Tribune reports the company revealed 39 cases where patients sustained damage to their arteries when doctors were installing the EnVeo R system. Of those, 19 patients died. The new instructions urge physicians not the force the catheter into place and to also pay close attention to patients who may have weakened arteries. If the device is forced, it could unintentionally “puncture or damage” a blood vessel during the procedure, the Star Tribune said, citing the letter.
The EnVeo R system has been installed in 24,000 people worldwide, the Minneapolis/ St. Paul Business Journal reported, with about 7,300 used in the United States. With only 39 reported cases of injury, Medtronic said that is lower than complication rates for other valve therapy treatments, the Journal noted.
The EnVeo R device is approved in the United States for patients who are at high risk of complications from traditional heart surgery. Use of the valve requires less recovery time than traditional surgery. The majority of the patients in the U.S. who have the catheter installed tend to be older and more frail, the Star Tribune said.
The letter issued by Medtronic amounts to a recall, but no device will actually be recalled since the catheter itself is not defective, only the installation procedure. Last year Medtronic, which has a large operations center in Minnesota, issued a recall of the EnVeo R Loading system due to the presence of particulates.
To help physicians learn to install the device properly, Medtronic developed three-dimensional models of “tortuous blood-vessel networks.” Doctors are encouraged to study live motion X-rays of their patients in order to prevent any issue with the installation. If a doctor encounters resistance during installation, they should stop the procedure and carefully examine the vascular system of the patient. If no damage is shown, physicians may restart the procedure, but are encouraged to use a stiffer guidewire, another device or look for another access point, Mass Device noted.
Earlier this month, Medtronic launched its MiniMed 630G system with SmartGuard technology for the treatment of people with diabetes mellitus sixteen years of age and older. The MiniMed 630G features a new insulin pump hardware platform.