PROMUS Element™ Plus H7493911424250Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729807858), received between Feb 27, 2017 and Feb 27, 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.

• InjuryFeb 27, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SAME CASE AS MDR ID #: 2134265-2017-01569. (B)(6)CLINICAL STUDY. IT WAS REPORTED THAT CHEST DISCOMFORT OCCURRED. IN (B)(6) 2013, THE PATIENT PRESENTED DUE TO CHEST PAIN AND WAS REFERRED FOR CARDIAC CATHETERIZATION. SUBSEQUENTLY, INDEX PROCEDURE WAS PERFORMED. THE TARGET LESION# 1 WAS A DE NOVO LESION, LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH 95% STENOSIS AND WAS 6 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.25MM. THE LESION WAS TREATED WITH DIRECT STENT PLACEMENT USING 2.25X8MM PROMUS ELEMENT¿ PLUS STENT RESULTING IN 0% STENOSIS. THE TARGET LESION #2 WAS A DE NOVO LESION LOCATED IN THE PROXIMAL LEFT CIRCUMFLEX (LCX) WITH 85% STENOSIS AND WAS 22MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.50 MM. THE LESION WAS TREATED WITH DIRECT STENT PLACEMENT USING 2.50X24MM PROMUS ELEMENT¿ PLUS STENT RESULTING IN 0% STENOSIS. ONE DAY POST PROCEDURE, THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2016, THE PATIENT PRESENTED FOR FOLLOW-UP AND HAD ONGOING SYMPTOMS OF EXERTIONAL AND RESTING CHEST HEAVINESS. THE SYMPTOMS GOT RELIEVED BY NITROGLYCERINE AND THE PATIENT WAS REFERRED FOR CARDIAC CATHETERIZATION. 99% IN-STENT RESTENOSIS OF THE MID LAD WAS TREATED

  Patient problems: Chest Tightness/Pressure

  MAUDE report 6362407 ↗