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    Posted April 6, 2014 by
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    Orange County Register Reports: FDA warns Edwards over broken heart devices

     
    http://www.ocregister.com/articles/edwards-512121-fda-company.html

    " By TONY SAAVEDRA and BERNARD J. WOLFSON / ORANGE COUNTY REGISTER
    Published: June 10, 2013 Updated: Aug. 21, 2013 1:17 p.m.
    edwards-headquarters-irvi
    FILE PHOTO: YGNACIO NANETTI, ORANGE COUNTY REGISTER
    Heart devices made by Edwards Lifesciences Inc. fell apart during surgery, requiring second operations to retrieve the broken bits from inside patients, according to a warning letter by federal regulators citing quality control problems at the company's factory in Draper, Utah.
    The letter, sent May 24 by the U.S. Food and Drug Administration and recently made public, cited several areas of concern and noted cases in which the Irvine-based company failed to investigate the problems that were brought to its attention or to identify the corrections needed.
    Raj Denhoy, an analyst with Jeffries LLC, said the problems cited by the FDA are not of serious concern to investors at this point, partly because they seem to be contained to a very small segment of Edwards' business. The company says that the products cited by the FDA accounted for $9 million of its sales last year, less than 0.5 percent of its $1.9 billion in revenue.
    Edwards said it was still drafting its response to the FDA letter and could not comment on any of the specifics contained in it. However, the company said it was "committed to thoroughly addressing the issues identified with the quality systems for our (cardiac surgery) devices." The company said, "We are also committed to implementing best-in-class quality systems and continue to make substantive changes and improvements in the quality of these systems."
    The FDA, following a month-long inspection of the plant, cited numerous faults:
    •In six cases, tubes used to drain non-oxygenated blood from veins that feed the heart broke during cardiac surgery, and four of them required a second surgery to remove the broken parts. The letter said that oven temperatures in the manufacturing process were not high enough to bond the components of the tubes. Edwards said the tubing broke because surgeons were inserting the device through the skin, but the FDA noted that this method was not incompatible with the instructions for use. Edwards has started a global recall of the tubing in question, the Quickdraw Venous Cannula.
    •Some devices made at the plant were adulterated and not being manufactured, used or stored within federal regulations. There were 39 complaints of particulates contaminating devices, including a 9 mm hair found in the sealed pouch of a heart tube, which was of "potential harm to the patient."
    •There were conflicts between the official instructions and the way trainers were preparing doctors to use a special clamp used to block the aorta during bypass surgery.
    •Another device used during coronary bypass surgery led to blood leaks that "could result in significant blood loss," according to at least 23 reports that Edwards filed with the FDA since October of last year. The company said it voluntarily withdrew that device from the market before the FDA concluded its inspection.
    Additionally, the FDA said all of the numerous devices Edwards makes with "Duraflo" coating – intended to reduce the risk of blood clots in heart surgery patients – are adulterated because Edwards does not have the necessary approval for the coating. A modification of the solvent used in Duraflo-coated devices "could significantly affect the safety or effectiveness of the device," the agency found.
    "As negative as they sound, these warning letters are not uncommon," said Denhoy, the analyst. "Not to downplay it, because these are serious issues, but devices are complex and sometimes these things happen."
    Edwards knows what it has to do, and as long as it resolves the issues the case can be closed without serious damage to the company, Denhoy said. But there could be a bigger problem if Edwards fails to satisfy the FDA and "this mushrooms into something bigger" and becomes "endemic," he said.
    That would be especially true if it were to affect the company's non-surgical Sapien heart valve, which is by far the company's biggest driver of sales growth. "But at this point, it is way premature to say anything like that," Denhoy said.
    The Utah plant makes other Edwards products – including components of the Sapien valve – which were not cited by the FDA. The agency told Edwards that its letter was "not intended to be an all-inclusive list of the violations at your firm's facility," adding that the issues cited "may be symptomatic of serious problems" in manufacturing and quality control at the plant. It urged Edwards to "take prompt actions" to correct the violations mentioned in the letter. In the meantime, there will be no new FDA approvals for devices "reasonably related" to the issues raised, it said.
    Edwards has hit some turbulence in recent months. Less than a month before the FDA sent its letter, the company's share price fell 22 percent in one day after it reported that U.S. sales of the Sapien valves in the first quarter had fallen short of expectations. Seven months earlier, the stock plunged 21 percent on a missed sales target."

    Photo Credit: http://www.guidedsolutions.co.uk/img/edwardslogo.jpg

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