Insights from the FDA’s MAUDE Database Regarding the Real-World Safety of Jetstream Atherectomy for Peripheral Arterial Disease

Rotational atherectomy has shown promise as an adjunctive therapy to percutaneous transluminal angioplasty (PTA) and stenting for the treatment of peripheral arterial disease (PAD) {1}. However, published data regarding the safety of these devices is limited. The Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database collects reports of adverse event for medical devices. We present three years of MAUDE adverse events data for the Jetstream Atherectomy System^TM (Boston Scientific) for the treatment of PAD.

Materials and Methods:

We searched MAUDE from January 1, 2019 to December 31, 2021. Duplicate reports and those with insufficient information were excluded, leaving a total of 500 reports for analysis. Adverse events were categorized as either patient complication, device malfunction or both. Adverse events were classified using the Society of Interventional Radiology’s (SIR) classification system for adverse events.

Results: The most common patient complications were embolism (22; 4.4%), dissection (17; 3.4%), vessel perforation (12; 2.4%), and device fracture in the patient (6; 1.2%). The most common modes of device failure were entrapment of the device on the guidewire (134; 27%), loss of blade rotation (116; 23%), loss of aspiration (99; 20%), and mechanical damage (57; 11%). There were 24 reports of a device malfunction with related patient harm. This represents 45.2% (24/53) of all patient complications in this study and 5.2% (24/470) of all device malfunctions. As per the SIR classification, most events did not require substantial therapy (471; 94%), followed by those requiring moderate escalation of care and substantial treatment (25; 5.0%); a small minority of events required significant escalation of care (3; 0.6%). 106 devices (21%) were returned for manufacturer analysis. Of these, the root cause of device failure was identified in 81 (76%) of devices.

Conclusion:

We highlight important adverse events encountered in real-world practice with the Jetstream Atherectomy System. This analysis provides further understanding of the safety profile and modes of failure of Jetstream and could help guide improvements in product design and manufacturer-user training.