UPDATE: FDA warns doc on CoreValve heart implant trial record-keeping issues

Medtronic's CoreValve heart implant

UPDATED March 1, 2013, 2 p.m. EST with comment from Medtronic.

Hard on the heels of a regulatory win in Europe for 1 of its heart implants, Medtronic (NYSE:MDT) got some bad news from the FDA regarding another.

Yesterday Fridley, Minn.-based Medtronic won CE Mark approval in the European Union for its next-generation Engager transcatheter aortic valve implant. Today the FDA revealed a warning to a doctor participating in a clinical trial of the medical device company’s CoreValve transcatheter aortic valve implant concerning "serious violations" uncovered during inspections last summer.

In a Jan. 14 warning letter sent to Dr. Michael Ring of the Providence Spokane Heart Institute, the federal watchdog agency said inspections in July and August 2012 found "objectionable conditions" at Ring’s arm of Medtronic’s U.S pivotal trial for the CoreValve device – and violations of his agreement with Medtronic to boot, according to the letter.

The FDA said Ring failed to report 2 patient deaths until months after they occurred, citing 2 instances and saying the lapse "can make the data unreliable."

"Your response to this observation appears to be adequate. You stated that you will notify the [institutional review board] within 5 days of becoming aware of the death of a subject or adverse event suffered by a subject who signed a unified informed consent document and that you will retrain study staff on reporting deaths," according to the agency.

The violations also included failure to conduct the trial "in accordance with the signed agreement with the sponsor, the investigational plan, applicable FDA regulations, and any conditions of approval imposed by an IRB or FDA, and failure to notify the sponsor and reviewing IRB of any deviation from the investigational plan to protect the life or physical well-being of a subject in an emergency within 5 working days after the emergency occurred," the FDA said. In 2 cases patients underwent emergency procedures that were not part of the investigational plan, 1 of which went unreported and another that wasn’t recorded until more than a month later, the agency said.

Ring’s response that time was inadequate because he didn’t specify a reporting procedure to prevent a recurrence, the FDA added.
Ring also failed to prevent patients from being randomized in the trial before signing the release, the FDA said, citing 3 instances and saying his proposed solution was "inadequate" because it didn’t specify a mechanism to prevent future infractions.

And he failed to obtain informed consent from patients before performing "invasive, research-specific screening tests, such as CT angiogram," but has since rectified the lapses. The agency cited 1 instance in which an unidentified patient signed the consent a day after an angiogram and another in which the patient never signed the form.

The bureau also tagged Ring for failing to "maintain accurate, complete, and current records" and of the research protocols.

Medtronic spokeswoman Kathleen Janasz told MassDevice.com in an email that the company halted its CoreValve program at Providence Spokane Heart Institute after the initial form 483 warning from the FDA.

“Medtronic is aware of the warning letter received by 1 our 2 site [principal investigators] at Providence Spokane Heart Institute and has been working closely with that site to address FDA’s concerns. While unfortunate, these are site-specific findings and will not impact the overall Medtronic CoreValve Clinical trial,” Janasz wrote. “The Providence Spokane Heart Institute is not currently implanting CoreValve devices, as Medtronic suspended procedures at the site at the time FDA issued its 483 findings. We will not resume implants at the site until all of FDA’s concerns are addressed to the full satisfaction of the FDA.”

MDT shares were down less than 1% today as of about 10 a.m. to $44.46 apiece.

The Engager CE Mark indication includes approval for transapical delivery of the valve in treatment of patients with aortic stenosis who are too sick to undergo traditional surgery.

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