PROMUS Element™ Plus H7493911420250Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729807841), received between Aug 22, 2018 and Aug 22, 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.

• DeathAug 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) CLINICAL STUDY. IT WAS REPORTED THAT THE PATIENT DIED. IN (B)(6) 2013, CLINICAL STATUS ASSESSMENT INDICATED THAT THE PATIENT'S QUALIFYING CONDITION WAS UNSTABLE ANGINA. PRIOR TO PROCEDURE, THE PATIENT WAS NOTED TO HAVE ELEVATED BIOMARKERS INDICATIVE OF ISCHEMIA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. SUBSEQUENTLY, INDEX PROCEDURE WAS PERFORMED. THE TARGET LESION #1 WAS LOCATED IN THE RAMUS WITH 70% STENOSIS AND WAS 15 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5 MM. THE LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.5X20MM STUDY STENT WITH 5% RESIDUAL STENOSIS, AND TIMI 3 FLOW. THE TARGET LESION # 2 WAS LOCATED IN THE 1ST OBTUSE MARGINAL WITH 70% STENOSIS AND WAS 22MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.25MM. THE LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.25 X 28 MM STUDY STENT WITH 1% RESIDUAL STENOSIS AND TIMI 3 FLOW. THREE DAYS LATER, THE PATIENT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY. IN (B)(6) 2017, THE PATIENT WAS ADMITTED IN THE HOSPITAL. THREE DAYS LATER, THE PATIENT DIED DUE TO CARDIAC ARREST.

  Patient problems: Cardiac Arrest; Death; Encephalopathy

  MAUDE report 7806412 ↗