Death Reporting Response To A Meta-Analysis Warning Of Increased Mortality Following Use Of Drug Coated Balloons
Michael Andrews, BS, Abraham Korn, MD, Michael F. Amendola, MD, FACS, Daniel Newton, MD.
Virginia Commonwealth University, Richmond, VA, USA.
OBJECTIVES:The Manufacturer and User Facility Device Experience (MAUDE) Database was established by the Food and Drug Administration (FDA) to allow for voluntarily reporting of adverse outcomes of medical devices. Recent meta-analysis published on December 6, 2018 has implicated drug coated balloon (DCB) treatment as a possible factor that increases mortality at two and five years in patients with peripheral vascular disease. We sought to examine MAUDE mortality trends for DCBs before and after the publication of this finding.
METHODS:All MAUDE database reports for drug coated balloons IN.PACT Admiral DCB (Medtronic - FDA approved 12/30/2014), LUTONIX DCB (BD/BARD - FDA approved 10/09/2014), and Stellarex DCB (Philips - FDA approved 7/26/2017) were accessed on December 23, 2019. Results of reported death outcomes were tabulated, and the reporting dates were analyzed over time to examine the change in reporting 12 months before and after the meta-analysis publication. The event descriptions for each death report were read and categorized accordingly. Fishers Exact analysis was used to establish statistical significance.
RESULTS:Prior to the meta-analysis publication, 56 total death reports were received regarding the DCBs. In the 12 months following the publication, 99 total death reports were received. Of the 155 total death reports submitted, reporters indicated 2 were possibly attributed to the device, 2 were possibly attributed to the procedure, and 0 were possibly attributed to the drug.
CONCLUSIONS:
Total reporting of deaths in patients treated with the DCBs increased significantly in the 12 months following the publication of the meta-analysis. The reported death attributions overall have not been highly indicative of these deaths being ascribed to the DCB device, procedure, or Paclitaxel drug. The data will inform vascular surgeons that death reports are on the rise following this warning.
| Death/Total(%) | Death/Total(%) | p-value | |
| In.Pact | 5/70 (7.1) | 11/75 (15) | 0.18 |
| Lutonix | 0/232 (0) | 2/123 (1.6) | 0.11 |
| Stellarex | 15/73 (21) | 86/366 (24) | 0.64 |
| Total | 20/375 (5.3) | 99/586 (17) | 0.0001 |
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