PROMUS Element™ Plus H7493911424270Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729807919), received between Mar 24, 2017 and Mar 24, 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 24, 2017Occlusion Within Device; Adverse Event Without Identified Device or Use Problem; Occlusion Within Device; Adverse Event Without Identified Device or Use Problem

  (B)(4). IT WAS REPORTED THAT THE PATIENT DIED. IN (B)(6) 2013, THE PATIENT WAS REFERRED FOR CARDIAC CATHETERIZATION AND CORONARY ANGIOGRAPHY REVEALED 90% STENOSIS IN MID RIGHT CORONARY ARTERY (RCA). SUBSEQUENTLY, INDEX PROCEDURE WAS PERFORMED. THE TARGET LESION WAS LOCATED IN THE MID RCA WITH 90 % STENOSIS AND WAS 16MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.0MM. THE TARGET LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF 2.75X24MM PROMUS ELEMENT¿ PLUS DRUG-ELUTING STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. ONE DAY POST PROCEDURE, THE PATIENT WAS DISCHARGED ON ASPIRIN, CLOPIDOGREL AND PRASUGREL. IN (B)(6) 2017, THE PATIENT EXPIRED.

  Patient problems: Death; Thrombosis

  MAUDE report 6433099 ↗