PROMUS Element™ Plus H7493911612270Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729807438), received between Mar 13, 2018 and Mar 13, 2018 — 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.

• InjuryMar 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4) CLINICAL STUDY. IT WAS REPORTED THAT PATIENT EXPERIENCED ANGINA. IN (B)(6) 2013, THE PATIENT PRESENTED DUE TO UNSTABLE ANGINA AND MYOCARDIAL INFARCTION AND PATIENT WAS REFERRED URGENTLY FOR CARDIAC CATHETERIZATION. SUBSEQUENTLY,CORONARY ANGIOGRAPHY AND INDEX WERE PERFORMED. TARGET LESION WAS A DE NOVO LESION LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY WITH 100% STENOSIS AND WAS 8MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.75MM. THE LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.75MM X 2MM PROMUS ELEMENT¿ PLUS STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0% AND TIMI 3 FLOW NOTED. THREE DAYS POST PROCEDURE, THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL. IN (B)(6) 2017, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH THE SYMPTOMS OF UNSTABLE ANGINA AND WAS HOSPITALIZED ON THE SAME DAY. ANGIO WITHOUT REVASCULARIZATION WAS PERFORMED IN RESPONSE TO THE EVENT. ON THE FOLLOWING DAY, THE EVENT WAS CONSIDERED AS RESOLVED AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL.

  Patient problems: Angina

  MAUDE report 7335025 ↗