A just-released federal inspection report on Sylmar, California’s St. Jude Medical facility is raising concerns.
The report, released by the U.S Food & Drug Administration (FDA), revealed serious flaws in St. Jude’s testing and its oversight of what The New York Times described as a “controversial heart device component.”
The report also highlights issues with how executives at St. Jude recently portrayed the inspection’s contents to its investors and other concerned parties and entities.
The report focused on how St. Jude handled Durata, a key electrical wire that connects to an implanted defibrillator that is, then, implanted to a patient’s heart, explained The New York Times. For this device, St. Jude uses a material called Optim to insulate the component and preserve its electronics; however, the durability of Optim has come into question following the failure of another St. Jude lead that uses a prior material and that was recalled, The New York Times said.
This October, St. Jude filed an iteration of the inspection report with the Securities and Exchange Commission (SEC). The submitted report had several blacked out portions that referred to the Durata. The firm said it redacted the report due to what it said was its “good faith interpretation” of how the FDA would respond when it released the document in compliance with a Freedom of Information Act request, The New York Times said. The agency did not redact product names when it released the report.
St. Jude spokeswoman, Amy Jo Meyer, said that none of the observations in the inspection report “identified a specific issue regarding the clinical or field performance of any of our products,” according to The New York Times. The company made no other comment, citing confidentiality of company communications with regulatory agencies.
As we’ve written, late last year, St. Jude issued a Class I recall on its line of Riata and Riata ST cardiac defibrillator leads after they were linked to a defect known as “inside-out corrosion.” This defect causes the conductive ends of the Riata leads to break from their protective housing, causing an implanted heart defibrillator to malfunction.
The Riata leads have been linked to more than 20 deaths and tens of thousands of people still rely on these questionable wires to deliver life-saving shocks to their heart, something that isn’t guaranteed if corrosion becomes an issue. After the recall, with these thousands of people left wondering how they should proceed with the faulty lead wires implanted, the FDA determined that patients with the Riata should consult their physicians and be vigilant for signs that their Riata leads were malfunctioning. The agency ruled against telling people to have replacement surgeries to remove the defective leads because that procedure carries its own life-threatening risks.
In response to the failed Riata leads, St. Jude recently released the Durata lead with the Optim component; however, like its predecessor, the Durata has also been the subject of some adverse event reports during its short time on the market.
Although St. Jude redacted a number of the September and October inspection details, the report focused on the way in which St. Jude tested the Durata. The New York Times noted that agency inspections revealed that St. Jude did not appropriately evaluate some study results and concluded that the firm did not correctly follow up on issues it identified during manufacturing and did not appropriately investigate complaints involving the Durata.
Some 278,000 patients have been implanted with the Durata, according to St. Jude, said The New York Times.