PROMUS Element™ Plus H7493911416400Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729808077), received between Apr 4, 2018 and Apr 4, 2018 — classified as 1 death.

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.

• DeathApr 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PROMUS ELEMENT PLUS CLINICAL STUDY IT WAS REPORTED THAT THE PATIENT DIED. IN (B)(6) 2013, THE PATIENT WAS DIAGNOSED WITH UNSTABLE ANGINA. SUBSEQUENTLY, THE PATIENT WAS REFERRED FOR CARDIAC CATHETERIZATION AND THE INDEX PROCEDURE WAS PERFORMED ON THE SAME DAY. THE TARGET LESION# 1 WAS LOCATED IN THE FIRST OBTUSE MARGINAL BRANCH WITH 80% IN-STENT RESTENOSIS OF A PREVIOUSLY DEPLOYED UNKNOWN DRUG-ELUTING STENT (DES) AND WAS 14MM LONG WITH REFERENCE VESSEL DIAMETER OF 4 MM. THE LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 4.00 X16MM PROMUS ELEMENT¿ PLUS DES. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 20%. ONE DAY POST PROCEDURE, THE PATIENT WAS DISCHARGED ON ASPIRIN AND TICAGRELOR. DURING THE 5-YEAR FOLLOW-UP, THE SITE BECAME AWARE THAT THE PATIENT WAS IN A NURSING HOME AND WAS NOT ASSESSABLE FOR THE FOLLOW-UP. THE PATIENT EXPIRED IN THE NURSING HOME ON AN UNKNOWN DATE OF UNKNOWN CAUSE.

  Patient problems: Death

  MAUDE report 7397992 ↗