Guidant Medical Device Press Articles

Pioneer Press, "FDA ups risk of Guidant defects"

          A potentially deadly short-circuiting problem with implantable defibrillators made by the former Guidant Corp. may be far more common than initially indicated, according to an analysis by federal regulators. More...

Associated Press, "More defibrillators, pacemakers recalled"

          Boston Scientific Corp. on Monday said it is recalling some defibrillator and pacemaker models that could fail because of an electrical flaw. The recall is the latest in a string of product problems Boston Scientific inherited when it bought Guidant Corp. in April for $27 billion. More...

Associated Press, "Guidant Weighed Warning Doctors"

          Newly unsealed court documents show that Guidant Corp. drafted a letter warning doctors of a dangerous electrical malfunction in some of its devices designed to restore a normal heartbeat, but the letter was never sent. More...

The New York Times, "Replacing Heart Device Found Risky; It may be safer to leave possibly defective defibrillators in patients, studies show"

         Surgery to replace potentially defective heart defibrillators carries an unexpectedly high rate of serious complications, including death, according to a study published today. The research in the Journal of the American Medical Association showed that one in 50 patients needed to have the replacement device removed because of severe postoperative infections.
          Dr. Andrew D. Krahn of Canada's University of Western Ontario and one of the study's authors said the overall complication rate was three to five times higher than expected. "We were absolutely surprised by these numbers," he said.
          Two other studies in the journal tracked the annual malfunction rate of defibrillators, which started rising in the late 1990s as the devices became more complex but began falling in 2002. It is now less than 1%. Taken together, the three studies paint the fullest picture yet of the risks to patients of removing or retaining a defibrillator recalled by its manufacturer.

The New York Times, "Guidant Withdraws Stents After Discovering Defects"

          The troubled Guidant Corporation announced yesterday that it would scrap Xience heart stents that had been manufactured for sale in Europe and for clinical testing in Japan after discovering that some of them had defects. Guidant said the action would result in a $15 million write-off in the first quarter.
          Guidant did not identify the defects, saying only that they resulted from a production problem, which it also declined to identify. The company said the production problem had been fixed after the company found that a small number -- about 1 percent -- of the devices being made at the plant in Temecula, Calif., were failing to meet its specifications.

New York Times, "Flaws cited in Guidant's review system; Panel suggests new group to monitor safety"

          An expert panel commissioned in summer by the Guidant Corp. to review its handling of heart-device flaws said Monday that the company had systematically failed to fully assess patient safety in deciding whether to publicize product failures.
          The group found that decisions made by Guidant about how to address or disclose product problems were driven by statistical projections from engineers rather than assessments from doctors about the medical consequences of those failures. The group urged Guidant to create an outside panel of physicians and others who would regularly monitor the safety of its devices and advise the company about when and how to notify doctors and patients about problems.
          In May, Guidant found itself at the center of a growing debate after it was disclosed that the company had not told doctors for three years about an electrical flaw in one of its defibrillators, an implanted device meant to interrupt a potentially fatal heart rhythm. Company executives defended their actions by maintaining that the device met all engineering projections and by asserting that notifying doctors about the flaw might result in more patient harm than good by causing unnecessary surgery to remove the devices and replace them.
          The 12-member panel sharply rejected Guidant's arguments, concluding that defects that posed significant risks to patients needed to be promptly disclosed, even when they occurred in small numbers. "The Independent Panel believes that under no circumstances should a potential or manifest risk of a preventable death be superseded by statistical analyses that indicate that performance remains with general guidelines," the panel concluded. At least seven patients have died in episodes in which Guidant defibrillators failed to work because of an electrical defect.

San Francisco Chronicle, "Guidant Warns Doctors on Defibrillators"

          Guidant Corp., which is being acquired for $27 billion by Boston Scientific Corp., cautioned doctors Monday to check the voltage on certain implantable defibrillators after the company received several reports of defective devices. The Indianapolis-based medical device maker issued the warning for its Contak Renewal 3 RF and Contak Renewal 4 RF models of defibrillators, which are devices that shock the heart back to a normal rhythm.
          Guidant said it had received 39 reports from doctors saying defibrillators that had been tested before being implanted had a lower-than-expected battery voltage. None of the 39 devices were put into patients. The voltage decline is related to a sustained, low level current that can only occur during storage and shipment before implantation. The company said about 4,000 Contak Renewal 3 RF and Contak Renewal 4 RF models have already been implanted, but it has not received any reports of this particular voltage problem.
          Guidant said that the Food and Drug Administration may classify the notification to doctors as a product recall. The company reminded doctors to check their inventory for the defect and to always perform the voltage check before implanting the device. The notification follows a long line of product woes for Guidant that started in the summer when the company recalled thousands of pacemakers and defibrillators for a variety of reasons.

New York Times, "Guidant Consultant Advised Company to Release Data on Defects"

          A consultant to the Guidant Corporation told the company last year that he believed it had a clear ethical obligation to tell physicians about heart device defects, and urged the company to overhaul its practices, newly released court records show.
          In two lengthy memos written just before Guidant was swamped by controversy, the consultant, Dr. Richard N. Fogoros, also told company executives that their decision to withhold such data, while statistically defensible, was questionable. Guidant executives have said they did not publicize defibrillator flaws because they believed that patients faced greater risks from replacement surgery than from the units.
          But Dr. Fogoros wrote in one memo that Guidant, while believing it was acting in the patients' best interest, had violated a "sacred obligation" it had to doctors by interposing its medical judgment for theirs. He also noted that Guidant had a clear conflict of interest that would naturally lead it to disclose product failures only when "absolutely necessary."

New York Times, "Internal Turmoil at Device Maker as Inquiry Grew"

          As the Guidant Corporation came under scrutiny last spring for not telling doctors about potentially fatal defects in its heart devices, the company's public message was upbeat and insistent: concerns about the safety of its products were overblown, it said, and perhaps even irresponsible.
          But newly released documents show that, inside Guidant, executives were struggling to contain a mounting crisis. The records illustrate how a series of miscalculations by Guidant, like its misreading of doctors' tolerance for being kept in the dark and its initial decision not to recall the devices, put the company on the defensive. As a result, company executives repeatedly changed course. More...

Associated Press, "Guidant Cited for Manufacturing Violations"

          Medical device maker Guidant Corp. waited more than a year to tell federal regulators that it had repaired software in a line of defibrillators, according to inspection documents released Thursday.
          An inspection report by the Food and Drug Administration said a flaw in Prizm, Prizm 2 and Vitality pulse generators caused the defibrillator to stop regulating patients' heart beats. Indianapolis-based Guidant developed software to fix the problem in May 2004, but did not submit the change to the FDA until August 2005, inspectors said. Inspectors discovered the omission this month as part of their 21-day examination at Guidant's St. Paul, Minn., facility.
          Fred McCoy, head of Guidant's cardiac division, acknowledged in a deposition last month that the company also did not get FDA approval to fix possibly fatal problems in Ventak Prizm 2 Model 1861. Of the two changes Guidant engineers made to that defibrillator, only one was disclosed in company filings.
          The company waited three years to disclose problems with the defibrillator.

Associated Press, "Guidant: FDA Incorrectly Told About Fixes"

          A Guidant Corp. executive acknowledged the medical device maker made changes to one of its defibrillators in 2002 and later incorrectly told federal regulators it had no effect on the product's performance.
          Still, Fred McCoy, head of Guidant's cardiac rhythm management division, said in a deposition released this week that he didn't think the faulty defibrillator was responsible for patients' deaths.
          "This particular failure mechanism does not have the capacity to kill a patient," McCoy said during a January deposition. "It may be unable, as a device, to save the patient."
          The defibrillator, a Ventak Prizm 2 Model 1861, was among some 88,000 recalled by the Indianapolis-based company since June. Guidant also recalled or issued safety warnings for more than 200,000 pacemakers. At least seven deaths have been linked to the devices.

New York Times, "Guidant Reparation Is Criticized"

          Guidant Corp.'s program to pay $2,500 to patients to replace a heart device that has had malfunctions is nowhere near sufficient to cover costs of the procedure, say plaintiff attorneys who are in consolidated litigation with the company.
          Charles S. Zimmerman, one of the plaintiffs' lead attorneys in litigation in Minneapolis, contended that the $2,500 offered by Guidant is "less than 10% of the cost of replacement." The multidistrict litigation, centered in federal district court in Minneapolis, brings all or nearly all the litigation against Guidant into one location. More...