Last week, the FDA warned manufacturer St. Jude that quality control and design problems related to the Durata ICD lead must be resolved within 15 days from the date of the letter (January 10) or the firm would face additional action, such as fines, seizures, or injunctions against selling the leads or other products. In a report to the Securities and Exchange Commission, St. Jude noted that the FDA letter did not specifically raise questions about the quality or function of the Durata leads, which it would continue to manufacture and sell.
A Troubled History
The Durata, like other similar leads, connects the implantable cardioverter defibrillator (ICD), to the heart, allowing the ICD to deliver life-saving shocks as necessary to ensure proper heart rhythm. However, the Durata has been the focus of increasing scrutiny for potential failures over the past six months, culminating in the recent action.
The Durata is St. Jude’s follow-up to its notorious Riata leads, which were recalled in 2011 because failures in insulation could lead to numerous unnecessary shocks or prevent an ICD from delivering a life-saving shock. At the time of the recall, about 227,000 leads had been distributed and nearly 80,000 remained in patients in the US. At the time of the recall, St. Jude issued assurances that the Durata design and manufacturing process were superior, although the company still insisted that the Riata was safe.
A study published in March 2012 linked Riata and Riata ST lead failures to 22 deaths due to insulation failures. This was followed up in October by a study showing that Durata lead failures were linked to at least one death.
In October, the FDA was finishing up its inspection of St. Jude’s manufacturing facilities in Sylmar, California. The October 17 inspection report revealed 11 separate multifaceted problems relating to the design and manufacture of the Durata leads. Some of these problems related to failure to follow internal processes, but many of them represented important deviations from best manufacturing processes.
The FDA told St. Jude’s to fix the problems or face additional action.
Problems Not Fixed
The FDA’s warning letter states that St. Jude’s responses to five items on the inspection report were inadequate. The problems included:
- Performing inadequate inspections of products rather than ensuring the quality of manufacturing
- Failure to monitor important aspects of a process
- Testing leads only once, rather than five times as specified by their in-house testing methods
- Making specifications to match the manufactured product rather than manufacturing the product to meet specifications
- Failure to determine the effectiveness of corrective actions taken to alter the manufacturing process or even determine whether the corrective actions actually had a detrimental impact on the device
The FDA also stated that it considered the Durata leads to be “misbranded” because St. Jude failed to report malfunctions of the device to the FDA in a timely manner.
Although a spokeswoman for St. Jude said the malfunction reports related to leads that had not been implanted, one of the reports listed was cited in the original inspection report as being listed as “not implanted” when the device was actually implanted, then removed.
Recall on the Horizon?
Dr. Robert G. Hauser, the lead author on both the March and October studies criticizing St. Jude’s leads said that the failures they were seeing in the Durata leads were “a red flag” because they were similar to failures in the older Riata leads before they were recalled. However, some critics point out that Dr. Hauser did not compare the failure rates of Durata to those of other leads.
At this point, the FDA does not seem to be considering a recall of Durata leads and no one is recommending that these leads be removed. About 350,000 people have received the Durata leads or an updated Riata lead that uses the same insulation.