PROMUS Element™ Plus H7493911416220Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729807766), received between Nov 28, 2016 and Mar 5, 2018 — classified as 3 deaths.

The most frequently reported specific device problem is “Occlusion Within Device” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• DeathMar 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SAME CASE AS MDR ID# 2134265-2018-01509 AND 2134265-2018-01510. (B)(4) 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 15MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.25MM. TARGET LESION #1 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.25X16MM 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 26MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.25MM AND WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.25X8MM AND 2.25X20MM 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 WAS H

  Patient problems: Death; Myocardial Infarction

  MAUDE report 7314674 ↗
• DeathMar 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SAME CASE AS MDR ID 2134265-2018-01532. (B)(4) CLINICAL STUDY. IT WAS REPORTED THAT THE PATIENT DIED. IN (B)(6) 2013, THE PATIENT PRESENTED WITH STABLE ANGINA. SUBSEQUENTLY, THE PATIENT WAS REFERRED FOR CARDIAC CATHETERIZATION AND INDEX PROCEDURE WAS PERFORMED. THE TARGET LESION WAS A BIFURCATED, DE NOVO LESION LOCATED IN THE MIDDLE LEFT ANTERIOR DESCENDING (LAD) WITH 95 % STENOSIS AND WAS 12 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.25 MM. THE LESION WAS TREATED WITH A PLACEMENT OF A 2.25X16MM PROMUS ELEMENT¿ PLUS STUDY STENT WITH 5% RESIDUAL STENOSIS. TARGET LESION #2 WAS A DE NOVO LESION LOCATED IN THE PROXIMAL LAD WITH 70 % STENOSIS AND WAS 12 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5 MM. THE LESION WAS TREATED WITH DIRECT PLACEMENT OF 2.50X16 MM PROMUS ELEMENT¿ PLUS STUDY STENT WITH 5% RESIDUAL STENOSIS. THE FOLLOWING DAY, THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2017, THE PATIENT WAS TRANSFERRED TO THE STUDY HOSPITAL FOR EVALUATION OF ELEVATED TROPONIN LEVEL (0.990). A DAY PRIOR TO THE TRANSFER TO THE STUDY HOSPITAL THE TROPONIN VALUE WAS REPORTED TO BE 1.010. THE PATIENT WAS HOSPITALIZED ON THE SAME DAY AND WAS DIAGNOSED WITH ATRIAL FIBRILLA

  Patient problems: Atrial Fibrillation; Death

  MAUDE report 7314414 ↗
• DeathNov 28, 2016Occlusion Within Device; Adverse Event Without Identified Device or Use Problem; Occlusion Within Device; Adverse Event Without Identified Device or Use Problem

  SAME CASED AS MDR ID: 2134265-2016-10604. PROMUS ELEMENT¿ PLUS CLINICAL STUDY. IT WAS REPORTED THAT THE PATIENT DIED. IN (B)(6) 2012, THE PATIENT PRESENTED DUE TO UNSTABLE ANGINA. SUBSEQUENTLY, THE INDEX PROCEDURE WAS PERFORMED. THE TARGET LESION WAS A DE NOVO LESION LOCATED IN THE DISTAL LEFT CIRCUMFLEX (LCX) WITH 90% STENOSIS AND WAS 5 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.00 MM. THE TARGET LESION WAS TREATED WITH PREDILATATION AND PLACEMENT OF 2.25 X 12 MM AND 2.25 X 16 MM PROMUS ELEMENT¿ PLUS STENTS WITH 0% RESIDUAL STENOSIS. THE FOLLOWING DAY, THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2016, THE PATIENT EXPIRED. THE CAUSE OF DEATH WAS UNKNOWN.

  Patient problems: Death; Thrombosis

  MAUDE report 6129845 ↗