FDA Issues Warning Over Medtronic Study Site Due to Serious CoreValve Device Study and Consent Irregularities

The U.S. Food and Drug Administration (FDA) issued a warning letter to Spokane, Washington’s Providence Sacred Heart Medical Center over dangerously significant issues related to a study being conducted at the Center on a Medtronic cardiac device.

The Center is studying Medtronic’s CoreValve cardiac device, said Ring of Fire Radio. According to the warning, serious irregularities exist in the study of the device meant for patients diagnosed with severe aortic stenosis. The condition may cause heart failure and sudden cardiac death in patients. The device maker touted the CoreValve’s clinical trial and has ensured that the CoreValve is being used in collaboration with that trial.

This means that the clinical trial is using a “non-FDA approved investigational device,” noted Ring of Fire Radio, which is being used for “transcatheter aortic valve implantation (TAVI). The FDA described blatant clinical trial protocol violations, which prompted the regulator’s warning letter to the site of the trials, the device manufacturer, and key investigators.

According to the agency, four significant violations were cited, said Ring of Fire Radio, and these violations must be corrected and brought in compliance with applicable regulations.

  • A researcher involved in the trial neglected to obtain informed participant consent before subjecting patients to screening tests. These tests, noted Ring of Fire Radio, were study-specific—including CT angiograms—and involved risks to patients. Failure to obtain appropriate consent is a significant issue.
  • Some participants were involved in the clinical trial prior to signing consent forms. In fact, Ring of Fire Radio pointed out that, in one case, a consent form was signed in excess of two months after the clinical trial began.
  • Significant clinical events took place that were different from what was indicated in the original investigational plan, yet neither the manufacturer nor the Institutional Review Board received notification in a timely fashion. A patient underwent several surgeries, two were emergency surgeries; these events were not reported for over one month, which is well beyond the rule that mandates these events must be reported within five days. In another case, a patient underwent coronary bypass surgery and this information was never reported. Even more serious, two patients died and those deaths were reported late. Ring of Fire Radio pointed out that timely reporting is critical to safe clinical trials and provides the time and information needed to ensure appropriate adjustments are made and studies are ceased, when needed.
  • The FDA discovered flaws in the way in which general medical records concerning the study’s subjects were maintained. This included a failure to record baseline vital signs, laboratory values, and post-operative ECGs, said Ring of Fire Radio.

Medtronic says the violations are limited this one site.

Meanwhile, we previously wrote that Dr. David Gossman, who had worked at the Lahey Clinic Hospital, alleged he was terminated after speaking out about the financial relationship between Lahey Clinic and Medtronic Inc. At the time of the report, Grossman alleged that Medtronic proposed that Lahey Clinic have “access to the CoreValve, a new heart valve that will be in clinical trials in the U.S. soon, predicated on the purchase and increased utilization of other products made by Medtronic,” according to a prior Courthouse News Service report. Gossman said the 2009 offer violated ethical guidelines and was made to Dr. Thomas Piemonte, director of Interventional Cardiology and the Cardiac Catheterization Laboratory at Lahey Clinic. Grossman accused Piemonte of having a “significant financial interest in Medtronic.”

Gossman was fired soon after speaking out at a lecture concerning the board responsible for the Clinic’s medical research conduct, asking, hypothetically: “If a medical device company approaches a hospital offering access to a new investigational device, but predicates access to the device on increased utilization of other products sold by the company, what would be the position of the IRB regarding this arrangement?”

At the time of the report, Gossman sought damages for defamation and Whistleblower Act violations.

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