Philadelphia, PAIf a medical device isn’t recalled, chances are you won’t know it’s defective until research has been published, and then attorneys create an awareness. Sometimes the FDA sits on adverse event reports for years before warning the public. Case in point: the Stöckert 3T heater-cooler system. The FDA has been getting adverse event reports about the 3T since early 2010, but it only recently issued a public warning.
2006: The Stöckert 3T heater-cooler devices are made available in the US, and about 2,000 of the devices are in the US, according to the FDA. The manufacturer is LivaNova PLC, formerly Sorin Group Deutschland GmbH.
January 2010 - August 2015: FDA warned of at least 32 adverse event reports of infections linked to the devices from January 2010 to August 2015. Of those reports, eight were in the US, and most of the other 24 were in Western Europe.
Spring 2015: Investigators in Switzerland reported six patients infected with Mycobacterium chimaera, a species of nontuberculous mycobacterium ubiquitous in soil and water. The infected patients had undergone open-heart surgery that used contaminated heater-cooler devices during extracorporeal circulation.
July 2015: A study published in the Clinical Infectious Diseases medical journal found a risk of bacteria escaping from heater-cooler devices used during open-heart surgeries.
September 2015: The Washington Post reported that lighted tubes (duodenoscopes) used during surgery were linked to more than two dozen outbreaks of antibiotic-resistant infections or “superbugs” that sickened at least 250 patients in the US and Europe. Health officials say design flaws like the duodenoscope and Stockert 3T didn’t take into account how difficult the equipment is to clean.
October 26, 2015:CNN reported that “WellSpan York Hospital Notifies Open-Heart Surgery Patients of Possible Infection Risk”. About 1,300 open-heart surgery patients could have been exposed to a bacterial infection after identifying eight patients who contracted nontuberculous mycobacterium, or NTM. Four of those patients died. WellSpan York Hospital in York, Pennsylvania, is contacting all patients who underwent open-heart surgery between October 1, 2011, and July 24, 2015.
October 27, 2015: CDC issued recommendations to health officials, health care providers and health care facilities to be on the lookout for any such cases of NTM and to take steps to prevent them. It is working with local and state health officials, as well as the FDA.
December 2015: The FDA issued a warning letter to LivaNova PLC (formerly Sorin Group Deutschland GmbH) for its Stöckert 3T Heater-Cooler System after inspections conducted at facilities in Munich, Germany and Arvada, Colorado revealed significant issues, including quality system and premarket clearance violations.
April 2016: A European study shows a link between M. chimaera clinical samples from several European infected cardiothoracic patients, samples from the heater-cooler devices used during these patient's procedures, and environmental samples from the device manufacturer's production and servicing facility in Germany. The results of this paper suggest a direct link between the M. chimaera that infected European patients during open-chest cardiac surgery, and the M. chimaera isolated from the 3T heater-cooler model utilized during these patients' surgeries.
June 2016 : FDA says it received reports of U.S. patients infected with M. chimaera after undergoing cardiothoracic surgery that involved use of the 3T devices. Each of those reports related to 3T devices that were manufactured prior to September 2014.
July 2016 : A lawsuit filed by Phillip Lamar West and Karen Austin, husband and wife, against LivaNova PLC, Sorin Group Deutschland GMBH, and Sorin Group USA, Inc. states that West underwent an aortic valve replacement and a bypass procedure at Greenville Health System Hospital (“GHS”) in Greenville, South Carolina. During the procedure, the Sorin 3T Heater-Cooler System was used, exposing him to non-tuberculosis Mycobacteria. (Case 8:16-cv-02688-MGL)
Kenneth Piechowski underwent cardiac surgery in December 2014 at Penn Presbyterian Medical Center in Pennsylvania. The procedure was successful but in May he suffered a stroke, which he claims was caused by slow-growing bacteria that came from the 3T device used during his procedure. Piechowski’s lawsuit states that in March 2016, a Penn physician told him his infection likely came from the 3T heater-cooler.
October 2016: The FDA updated its June 2016 warning: “ Health care facilities should take additional steps to help mitigate the risk of infection associated with the use of these devices.”
Further, the agency said more than 500,000 patients in the U.S. who had open-heart surgery involving the use of a LivaNova heater-cooler device since 2012 could be at risk for “a deadly bacterial infection” [nontuberculous mycobacterium, or NTM]. “Over the past year, at least 28 NTM infections in patients undergoing open-heart surgery in U.S. hospitals have been linked to the devices. Infections have also been reported in Europe, with some patients diagnosed nearly 4 years after surgery.”
October 19, 2016: Another lawsuit is filed against LivaNova, alleging failure to warn hospitals and doctors of the increased risk of infections caused by the Stockert 3T during cardiothoracic surgeries, according to Philly.com.
Currently: Stockert 3T claims are mounting and attorneys are investigating…
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