PROMUS Element™ Plus H7493911428300Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729807988), received between Mar 23, 2017 and Apr 11, 2017 — classified as 2 deaths.

The most frequently reported specific device problem is “Occlusion Within Device” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• DeathApr 11, 2017Occlusion Within Device; Adverse Event Without Identified Device or Use Problem; Occlusion Within Device; Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT ADJUDICATION INDICATES STENT THROMBOSIS OCCURRED.

  Patient problems: Cardiac Arrest; Death; Dyspnea; Thrombosis

  MAUDE report 6483090 ↗
• DeathMar 23, 2017Occlusion Within Device; Occlusion Within Device

  (B)(6). IT WAS REPORTED THAT THE PATIENT DIED. IN (B)(6) 2013, THE PATIENT PRESENTED TO EMERGENCY DEPARTMENT. SUBSEQUENTLY, INDEX PROCEDURE WAS PERFORMED. TARGET LESION # 1 WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) WITH 80% STENOSIS AND WAS 25 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.00 MM. TARGET LESION # 1 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF 3.00 X 28 MM PROMUS ELEMENT¿ PLUS STENT. FOLLOWING POST-DILATATION, THE RESIDUAL STENOSIS WAS 0%. THE FOLLOWING DAY, THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL. IN (B)(6) 2016, THE PATIENT PRESENTED TO THE HOSPITAL WITH THE COMPLAINTS OF SEVERE CHEST PAIN. CARDIAC ENZYMES WERE NOTED TO BE ELEVATED AND THE PATIENT WAS DIAGNOSED WITH ACUTE ST ELEVATED ANTERIOR MYOCARDIAL INFARCTION (MI). THE PATIENT WAS IMMEDIATELY TRANSFERRED TO THE CARDIAC CATHETERIZATION LAB WHERE ANGIOGRAPHY REVEALED 100% STENOSIS OF PROXIMAL LAD WHICH WAS TREATED WITH BALLOON ANGIOPLASTY USING A 3.0 EMERGE¿ BALLOON CATHETER UP TO 12 ATMOSPHERES. POST PROCEDURAL STENOSIS WAS 50% WITH TIMI 3 FLOW RESTORED. DURING THE COURSE OF HOSPITALIZATION, THE SUBJECT WAS ALSO DIAGNOSED WITH ACUTE RESPIRATORY FAILURE SECONDARY TO SEVERE PULMONA

  Patient problems: Cardiogenic Shock; Chest Pain; Death; Intracranial Hemorrhage; Myocardial Infarction; Reocclusion; ST Segment Elevation; Thrombosis

  MAUDE report 6428835 ↗