PROMUS Element™ Plus H7493911438350Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729823766), received between Dec 6, 2016 and Oct 26, 2018 — classified as 1 death, 1 injury.

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

• InjuryOct 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) CLINICAL STUDY. IT WAS REPORTED THAT PATIENT EXPERIENCED ANGINA WITH ISCHEMIA AND TARGET VESSEL REVASCULARIZATION OCCURRED. IN (B)(6) 2013, THE PATIENT'S QUALIFYING CONDITION WAS STABLE ANGINA. ABNORMAL STRESS TEST OR IMAGING STRESS TEST INDICATED ISCHEMIA PRIOR TO PROCEDURE AND THE PATIENT WAS REFERRED FOR CARDIAC CATHETERIZATION AND INDEX PROCEDURE WAS PERFORMED ON THE SAME DAY. THE TARGET LESION WAS LOCATED IN THE DISTAL RIGHT CORONARY ARTERY (RCA) WITH 75% STENOSIS AND WAS 18 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.38 MM. THE LESION WAS TREATED WITH PRE-DILATATION AND DEPLOYMENT OF A 3.00 X 20 MM STUDY STENT. FOLLOWING POST-DILATATION, RESIDUAL STENOSIS WAS 0%. TARGET LESION #2 WAS LOCATED IN THE PROXIMAL RCA WITH 98% STENOSIS AND WAS 30 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.38 MM. TARGET LESION #2 WAS TREATED WITH PRE-DILATATION AND DEPLOYMENT OF A 3.50 X 32/38 MM STUDY STENT. FOLLOWING POST-DILATATION, RESIDUAL STENOSIS WAS 0%. TARGET LESION #3 WAS LOCATED IN THE 1ST OBTUSE MARGINAL WITH 86% STENOSIS AND WAS 34 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.47 MM. TARGET LESION #3 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.50 X 32/38 MM STUDY STE

  Patient problems: Angina; Ischemia; Reocclusion

  MAUDE report 8009663 ↗
• DeathDec 6, 2016Occlusion 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 STENT THROMBOSIS OCCURRED AS PER ADJUDICATION.

  Patient problems: Death; Thrombosis

  MAUDE report 6149479 ↗