PROMUS Element™ Plus H7493911428220Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729807797), received between Aug 22, 2018 and Dec 12, 2018 — classified as 2 deaths.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• DeathDec 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) CLINICAL STUDY. IT WAS REPORTED THAT CARDIAC ARREST OCCURRED AND PATIENT DIED. IN (B)(6) 2013, THE PATIENT'S QUALIFYING CONDITION WAS UNSTABLE ANGINA. THE PATIENT WAS FOUND TO HAVE ELEVATED BIOMARKERS WHICH EVIDENCES INDICATIVE OF ISCHEMIA AND WAS REFERRED FOR CARDIAC CATHETERIZATION WHICH RESULTED TO 80% STENOSIS IN THE PROXIMAL OBTUSE MARGINAL (OB) AND INDEX PROCEDURE WAS PERFORMED. TARGET LESION WAS LOCATED IN THE 1ST OB MARGINAL WITH 70% STENOSIS AND WAS 22MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.25MM. TARGET LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.5X28MM STUDY STENT AND THE RESIDUAL STENOSIS WAS FOUND TO BE 1%. TWO DAYS POST PROCEDURE, THE PATIENT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY. IN (B)(6) 2017, WHILE DIVING THE PATIENT WENT INTO CRA (CARDIAC RESPIRATORY ARREST). HE WAS GIVEN BASIC CARDIOPULMONARY RESUSCITATION (CPR) BY LIFEGUARDS FOR APPROXIMATELY 8 MINUTES. EMERGENCY MEDICAL SERVICES CONTINUED WITH ADVANCED CPR, FIRST HEART RATE WAS PULSELESS ELECTRICAL ACTIVITY. OROTRACHEAL INTUBATION WAS CONDUCTED WITH OROTRACHEAL TUBE CONDUCTED WITH OROTRACHEAL TUBE NUMBER 7 WITH FROVA ANTERIOR GLOTIC INTUBATION. AFTER 24 MIN OF CPR THE PATIENT

  Patient problems: Death

  MAUDE report 8155570 ↗
• 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)(4) 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 7807237 ↗