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Pulmonary artery sensor had more adverse events after FDA approval
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A wireless pulmonary artery sensor had higher risk for injury and the need for device recalibration or reintervention after its FDA approval than estimated in pre-approval data, according to an analysis published in JAMA Cardiology.
According to the researchers, the discrepancy may be due to the implantation of the device (CardioMEMS HF System, Abbott) in older patients with higher baseline pulmonary artery pressures and greater burden of medical comorbidities after it was approved by the FDA compared with those from the CHAMPION trial, on which approval was based.
Muthiah Vaduganathan, MD, MPH , clinical fellow in medicine at Brigham and Women’s Hospital, and colleagues analyzed data from the Manufacturer and User Facility Device Experience database from May 28, 2014, when the device received FDA premarket approval, to May 28, 2017.
There were more than 5,500 devices in the United States in the first 3 years after it received FDA approval, and 2.8% of devices had 177 unique adverse events. The majority of events (94.8%) were mandatorily reported by the user or manufacturer facility. Time between the event and when it was reported to the FDA was a median of 42 days.
Events that occurred with the device include pulmonary artery injury/hemoptysis (n = 28), technical challenges with implantation (n = 18), access site-related bleeding or infection (n = 15), pulmonary embolism or device thrombosis (n = 5), death (n = 22) and sensor malfunction, failure or migration (n = 46).
“Early detection of safety signals and general oversight of medical devices are challenging,” Vaduganathan and colleagues wrote. “The FDA receives more than 1 million device-related reports annually, but has limited resources, clinical reviewers and knowledge of total device use (the ‘denominator’) to understand their clinical significance. Future partnerships between regulators, industry sponsors and academia may help better triage available resources toward improving patient selection, operator experience or device technology to optimize device use in clinical practice.” – by Darlene Dobkowski
Disclosures: Vaduganathan reports no relevant financial disclosures. Please see the study for all other authors’ relevant financial disclosures.
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