PROMUS Element™ Plus H7493911424350Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729808039), received between Apr 6, 2017 and Apr 6, 2017 — classified as 1 injury.

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.

• InjuryApr 6, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) CLINICAL STUDY. IT WAS REPORTED THAT ATRIAL FLUTTER, ISCHEMIC CARDIOMYOPATHY AND MYOCARDIAL INFARCTION (MI) OCCURRED. IN (B)(6) 2012, THE PATIENT PRESENTED DUE TO UNSTABLE ANGINA AND MYOCARDIAL INFARCTION. SUBSEQUENTLY THE PATIENT WAS REFERRED FOR CARDIAC CATHETERIZATION AND INDEX PROCEDURE WAS PERFORMED. THE TARGET LESION #1 WAS A DE NOVO LESION LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) WITH 90% STENOSIS AND WAS 23 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.5 MM. THE TARGET LESION #1 WAS TREATED WITH DIRECT PLACEMENT OF A 3.50 X 24 MM PROMUS ELEMENT¿ PLUS STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 10%. THE TARGET LESION #2 WAS A DE NOVO LESION LOCATED IN THE 2ND DIAGONAL WITH 90% STENOSIS AND WAS 18 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.3 MM. THE TARGET LESION #2 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.25 MM X 20 MM PROMUS ELEMENT¿ PLUS STENT. FOLLOWING POST-DILATATION, RESIDUAL STENOSIS WAS 20%. FIVE DAYS AFTER, THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2017, THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH THE DIAGNOSIS OF "ATRIAL FLUTTER AND ISCHEMIC CARDIOMYOPATHY". CARDIAC ENZYME VALUES WERE NOTED TO

  Patient problems: Arrhythmia; Cardiac Enzyme Elevation; Cardiomyopathy; Ischemia; Myocardial Infarction

  MAUDE report 6465380 ↗