PROMUS Element™ Plus H7493911420220Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729807773), received between Mar 6, 2018 and Mar 6, 2018 — classified as 1 death.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• DeathMar 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SAME CASE AS MDR ID# 2134265-2018-01508 AND 2134265-2018-01509. (B)(6) CLINICAL STUDY. IT WAS REPORTED THAT MYOCARDIAL INFARCTION (MI) OCCURRED AND THE PATIENT DIED. IN (B)(6) 2013, THE PATIENT PRESENTED DUE TO STABLE ANGINA AND WAS REFERRED FOR ELECTIVE CARDIAC CATHETERIZATION. SUBSEQUENTLY, CORONARY ANGIOGRAPHY AND INDEX PROCEDURE WERE PERFORMED. TARGET LESION #1 WAS A DE NOVO LESION LOCATED IN THE DISTAL LEFT ANTERIOR DESCENDING ARTERY WITH 90% STENOSIS AND WAS 15 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.25 MM. TARGET LESION #1 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.25 X 16 MM PROMUS ELEMENT¿ PLUS STENT, WITH 0% RESIDUAL STENOSIS AND TIMI 3 FLOW NOTED. TARGET LESION #2 WAS A DE NOVO LESION LOCATED IN THE RIGHT POSTERIOR DESCENDING ARTERY WITH 90% STENOSIS AND WAS 26 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.25 MM AND WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.25 X 8 MM AND 2.25 X 20 MM PROMUS ELEMENT¿ PLUS STENTS. FOLLOWING POST-DILATATION, RESIDUAL STENOSIS WAS 0% AND TIMI 3 FLOW NOTED. THE FOLLOWING DAY, THE PATIENT WAS DISCHARGED ON ASPIRIN AND TICAGRELOR. IN (B)(6) 2017, THE PATIENT HAD A CARDIAC ARREST WHICH WAS FURTHER DIAGNOSED AS MI. THE

  Patient problems: Death; Myocardial Infarction

  MAUDE report 7318223 ↗