The Effects of a National Recall on the Reports to the FDA Manufacturer and User Facility Device Experience Database of a Common Atherectomy Device

Abstract

The HawkOne Directional Atherectomy System (Medtronic Inc., Minneapolis, MN) is a peripheral arterial disease management system that was recalled in December 2021 secondary to repeated guidewire prolapse. We set forth to analyze the patient problems and device issues that caused the device to be recalled and determine if the recall had a significant impact on the device reports utilizing the US Food and Drug Administration (FDA) database Manufacturer and User Facility Device Experience (MAUDE). MAUDE was queried for all adverse report events for the HawkOne device six months prior to and after its recall date in December 2021. Data collected included patient-based issues, device-based issues, and if the device was evaluated by the manufacturer. Fisher's exact test was utilized. There were 72 unique events reported prior to the device recall and 35 events reported after the recall. The majority of adverse events resulted in no adverse clinical outcomes before (55.6%) and after (21.3%) the recall. The most common reported device issue was detachment both before (54.8%) and after (57.1%) the recall. There was no significant difference in the rate of any patient outcome or device problem after the recall. The number of devices evaluated by the manufacturer after the recall was significantly reduced (69.9% vs 11.4%; P ≤ .001). There was no significant change in the rate of specific patient outcomes or device issues after the HawkOne device recall. The rate at which the devices were evaluated by the manufacturer significantly reduced after the recall. These data indicate possible influences that an official device recall might have on reporting to the MAUDE and warrant further study to understand the complexity of user-based feedback of such endovascular devices.