PROMUS Element™ Plus H7493911438300Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729823759), received between Mar 29, 2017 and Mar 29, 2017 — classified as 1 death.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• DeathMar 29, 2017Occlusion Within Device; Adverse Event Without Identified Device or Use Problem; Occlusion Within Device; Adverse Event Without Identified Device or Use Problem

  (B)(4) CLINICAL STUDY. IT WAS REPORTED THAT THE PATIENT DIED. IN (B)(6) 2013, THE PATIENT PRESENTED WITH STABLE ANGINA. SUBSEQUENTLY, INDEX PROCEDURE WAS PERFORMED. THE TARGET LESION WAS A DE NOVO LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) WITH 90% STENOSIS AND WAS 34 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.0 MM. THE TARGET LESION TREATED WITH DIRECT STENT PLACEMENT USING A 3.00 MM X 38 MM PROMUS ELEMENT¿ PLUS STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. THE FOLLOWING DAY, THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2017, THE PATIENT DIED DUE TO NATURAL CAUSES.

  Patient problems: Death; Heart Failure; High Blood Pressure/ Hypertension; Rheumatoid Arthritis; Thrombosis

  MAUDE report 6443169 ↗