PROMUS Element™ Plus H7493911420270Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729807902), received between Dec 6, 2016 and Sep 26, 2017 — classified as 1 death, 1 injury.

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 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.

• DeathSep 26, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) STUDY; IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY DRUG ELUTING STENTING TREATMENT PROCEDURE, THE PATIENT HAD BIVENTRICULAR HEART FAILURE AND EXPIRED. IN (B)(6) 2012, THE PATIENT PRESENTED DUE TO UNSTABLE ANGINA (BRAUNWALD CLASSIFICATION: IIIB) AND WAS REFERRED FOR CARDIAC CATHETERIZATION. THE DE NOVO TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (MID LAD) WITH 70% STENOSIS AND WAS 20MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.75MM. THE TARGET LESION WAS TREATED WITH PRE-DILATION AND PLACEMENT OF A 2.75X20MM PROMUS ELEMENT PLUS STENT, WITH 0% RESIDUAL STENOSIS FOLLOWING POST-DILATION. THE PATIENT WAS DISCHARGED ON ASPIRIN THE NEXT DAY. IN (B)(6) 2017, THE PATIENT EXPIRED. PER DEATH CERTIFICATE, THE PRIMARY AND IMMEDIATE CAUSE OF DEATH WAS ¿BIVENTRICULAR HEART FAILURE SECONDARY TO ISCHEMIC CARDIOMYOPATHY¿. IT WAS CONFIRMED THAT NO AUTOPSY WAS PERFORMED.

  Patient problems: Cardiomyopathy; Death; Heart Failure

  MAUDE report 6892993 ↗
• InjuryDec 6, 2016Occlusion Within Device; Adverse Event Without Identified Device or Use Problem; Occlusion Within Device; Adverse Event Without Identified Device or Use Problem

  SAME CASE AS MFR. REF.# 2134265-2016-11215. (B)(4). IT WAS REPORTED THAT IN-STENT RESTENOSIS (ISR) AND MYOCARDIAL INFARCTION (MI) OCCURRED. IN (B)(6) 2012, THE PATIENT PRESENTED WITH UNSTABLE ANGINA AND INDEX PROCEDURE WAS PERFORMED ON THE SAME DAY. THE TARGET LESION WAS DE NOVO LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH 70 % STENOSIS AND WAS 45 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5 MM. THE TARGET LESION WAS TREATED WITH DIRECT PLACEMENT OF A 2.50 MM X 28 MM AND 2.75 X 20 MM PE PLUS STENTS. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. THE PATIENT HAD SIGNIFICANT ANGINA AND HAD REPRODUCIBLE ANGINA WITH BALLOON OCCLUSION DURING LAD STENTING. THE MID LAD STENOSIS WAS LIKELY CULPRIT FOR ANGINA. SUBSEQUENTLY, THE PROXIMAL SEGMENT OF DIAGONAL ARTERY WAS ANGIOPLASTIED USING 1.5 X 1.5 MM APEX BALLOON CATHETER. AFTER 2 DAYS, THE PATIENT WAS DISCHARGED WITH ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2016, THE PATIENT WAS DIAGNOSED WITH ACUTE DECOMPENSATED SYSTOLIC HEART FAILURE AND THE PATIENT WAS HOSPITALIZED ON THE SAME DAY. THE PATIENT RECEIVED MEDICATION THERAPY IN RESPONSE TO THE EVENT. SIX DAYS POST-ADMISSION, OUTCOME OF THE EVENT WAS CONSIDERED AS R

  Patient problems: Angina; Cardiac Enzyme Elevation; Congestive Heart Failure; Dyspnea; Myocardial Infarction; Non specific EKG/ECG Changes; Reocclusion

  MAUDE report 6149474 ↗