PROMUS Element™ Plus H7493911408400Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729808114), received between Feb 8, 2017 and Feb 8, 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.

• DeathFeb 8, 2017Occlusion Within Device; Adverse Event Without Identified Device or Use Problem; Occlusion Within Device; Adverse Event Without Identified Device or Use Problem

  PROMUS ELEMENT PLUS CLINICAL STUDY. IT WAS REPORTED THAT THE PATIENT DIED. IN (B)(6) 2012, THE PATIENT WAS REFERRED FOR CARDIAC CATHETERIZATION. SUBSEQUENTLY, INDEX PROCEDURE WAS PERFORMED. THE TARGET LESION WAS A DE NOVO LESION LOCATED IN THE LEFT MAIN CORONARY ARTERY (LMCA) INVOLVING LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH 70% STENOSIS AND WAS 5 MM LONG WITH A UNKNOWN REFERENCE VESSEL DIAMETER. THE TARGET LESION WAS TREATED WITH DIRECT PLACEMENT OF 4.00 X 8.00 MM PE PLUS STENT WITH 0% RESIDUAL STENOSIS. TWO DAYS AFTER, THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL. IN (B)(6) 2016, THE PATIENT EXPIRED. PER PI NOTE DATED (B)(6) 2017, THE SITE BECAME AWARE OF PATIENT'S DEATH WHILE DOING SEARCH ON INTERNET REGARDING THE PATIENT. LAST CONTACT WITH THE PATIENT WAS IN (B)(6) 2016 VIA PHONE CALL. THE CAUSE OF DEATH WAS UNKNOWN. DEATH CERTIFICATE IS NOT AVAILABLE AND AUTOPSY WAS NOT PERFORMED.

  Patient problems: Death; Thrombosis

  MAUDE report 6312760 ↗