PROMUS Element™ Plus H7493911412350Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729808008), received between Mar 23, 2017 and Apr 11, 2017 — classified as 3 deaths.

The most frequently reported specific device problem is “Occlusion Within Device” (3 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 3 most recent of 3 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

  SAME CASE AS MDR ID: 2134265-2017-04007. (B)(6) CLINICAL STUDY. IT WAS REPORTED THAT THE PATIENT DIED. IN (B)(6) 2013, THE PATIENT PRESENTED DUE TO UNSTABLE ANGINA AND WAS DIAGNOSED WITH MYOCARDIAL INFARCTION (MI). SUBSEQUENTLY, CORONARY ANGIOGRAPHY AND INDEX PROCEDURE WERE PERFORMED. THE TARGET LESION #1 WAS A DE NOVO LESION LOCATED IN PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH 80% STENOSIS AND WAS 10MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.5MM. TARGET LESION #1 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 3.50X12MM PROMUS ELEMENT¿ PLUS DRUG-ELUTING STENT. FOLLOWING POST-DILATATION, THE RESIDUAL STENOSIS WAS 0%. THE TARGET LESION #2 WAS A DE NOVO LESION LOCATED IN DISTAL RIGHT CORONARY ARTERY (RCA) WITH 100% STENOSIS AND WAS 26MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.0MM. TARGET LESION #2 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 3.00X28MM PROMUS ELEMENT¿ PLUS DRUG-ELUTING STENT. FOLLOWING POST-DILATATION, THE RESIDUAL STENOSIS WAS 0%. ON THE FOLLOWING DAY, THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL. IN (B)(6) 2017, THE PATIENT WAS FOUND UNRESPONSIVE BY THE FAMILY IN THE HOME. SUBSEQUENTLY, THE PATIENT WAS BROUGHT TO EMERGENCY MEDICAL SER

  Patient problems: Cardiac Arrest; Death; Dyspnea; Thrombosis

  MAUDE report 6483128 ↗
• DeathApr 11, 2017Occlusion Within Device; Adverse Event Without Identified Device or Use Problem; Occlusion Within Device; Adverse Event Without Identified Device or Use Problem

  SAME CASE AS MDR# 2134265-2017-03330 AND 2134265-2017-03332. (B)(4) CLINICAL STUDY. IT WAS REPORTED THAT THE PATIENT DIED. IN (B)(6) 2013, THE PATIENT'S QUALIFYING CONDITION WAS UNSTABLE ANGINA. PRIOR TO PROCEDURE, THE PATIENT WAS FOUND TO HAVE ABNORMAL FRACTIONAL FLOW RESERVE INDICATIVE OF ISCHEMIA AND THE PATIENT WAS REFERRED FOR CARDIAC CATHETERIZATION. ON THE SAME DAY, THE INDEX PROCEDURE WAS PERFORMED. TARGET LESION #1 WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH 70% STENOSIS AND WAS 16 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.00 MM. TARGET LESION #1 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF 3.00X20MM STUDY STENT. FOLLOWING POST-DILATATION, RESIDUAL STENOSIS WAS 0%. TARGET LESION #2 WAS LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA) WITH 65% STENOSIS AND WAS 10 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.5 MM. TARGET LESION #2 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF 3.50X12MM STUDY STENT. FOLLOWING POST-DILATATION, RESIDUAL STENOSIS WAS 0%. TARGET LESION #3 WAS LOCATED IN THE PROXIMAL RCA WITH 75% STENOSIS AND WAS 12 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.5 MM. TARGET LESION #3 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF

  Patient problems: Death; Sudden Cardiac Death; Thrombosis

  MAUDE report 6479497 ↗
• DeathMar 23, 2017Occlusion Within Device; Adverse Event Without Identified Device or Use Problem; Occlusion Within Device; Adverse Event Without Identified Device or Use Problem

  (B)(4) CLINICAL STUDY. IT WAS REPORTED THAT THE PATIENT DIED. IN (B)(6) 2013, THE PATIENT PRESENTED DUE TO STABLE ANGINA AND WAS REFERRED FOR ELECTIVE CARDIAC CATHETERIZATION. SUBSEQUENTLY, INDEX PROCEDURE AND CORONARY ANGIOGRAPHY WERE PERFORMED. THE TARGET LESION WAS A DE NOVO LESION LOCATED IN THE PROXIMAL LEFT CIRCUMFLEX (LCX) ARTERY WITH 70% STENOSIS AND WAS 10MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.5MM. THE TARGET LESION WAS TREATED WITH DIRECT STENT PLACEMENT USING A 3.50X12MM PROMUS ELEMENT¿ PLUS DRUG-ELUTING STUDY STENT WITH 0% RESIDUAL STENOSIS. ON THE FOLLOWING DAY, THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL. IN (B)(6) 2016, THE PATIENT EXPIRED AND THE CAUSE OF DEATH WAS UNKNOWN.

  Patient problems: Death; Thrombosis

  MAUDE report 6427016 ↗