Reporters find heart devices skipped FDA’s more rigorous approval process

About Pia Christensen

Pia Christensen (@AHCJ_Pia) is the managing editor/online services for AHCJ. She manages the content and development of, coordinates AHCJ's social media efforts and edits and manages production of association guides, programs and newsletters.

Deborah L. Shelton and Jason Grotto of the Chicago Tribune couldn’t help but wonder: How does a medical device get implanted into patients without first getting FDA approval?

Tricuspid valve in a model heart
Tricuspid valve in a model heart. (Photo by robswatski via Flickr)

That question led to their two-day series in late May that reported for the first time that certain heart valve repair devices had been “down-classed” from class III to class II, a regulatory category that required that they undergo less scrutiny, even though the devices are permanently implanted and life-sustaining.

One of the annuloplasty rings had been stitched into the hearts of at least 700 patients in Chicago and elsewhere without going through proper channels. In fact, even though the company could have submitted both rings for clearance through a less rigorous regulatory pathway, it didn’t even do that. In these two cases, the process was skipped in its entirety.

In this article for AHCJ members, the pair explains how they reported the story, including finding documents and persuading affected patients to speak on the record.

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