PROMUS Element™ Plus H7493911412300Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729807940), received between Sep 18, 2017 and Dec 5, 2018 — classified as 3 deaths.

The most frequently reported specific device problem is “Obstruction of Flow” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• DeathDec 5, 2018Obstruction of Flow; Obstruction of Flow

  (B)(6) CLINICAL STUDY. IT WAS REPORTED THAT THE PATIENT DIED. IN (B)(6) 2013, THE CLINICAL STATUS ASSESSMENT INDICATED THAT THE PATIENT'S QUALIFYING CONDITION WAS STABLE ANGINA. PRIOR TO PROCEDURE, THE PATIENT WAS FOUND TO HAVE EVIDENCES OF ISCHEMIA AND THE PATIENT WAS REFERRED FOR CARDIAC CATHETERIZATION. THE INDEX PROCEDURE WAS PERFORMED ON THE SAME DAY. THE TARGET LESION# 1 WAS LOCATED IN THE FIRST OBTUSE MARGINAL BRANCH SEGMENT WITH 90% STENOSIS AND WAS 15MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.00 MM. THE LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 3.00X12MM STUDY STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 5%. ONE DAY POST PROCEDURE, THE PATIENT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY. IN (B)(6) 2018, THE PATIENT SUDDENLY FELT SICK AND COLLAPSED. IN (B)(6) 2018, DURING THE FOLLOW-UP, THE PATIENT'S RELATIVE WAS CONTACTED AND WAS INFORMED ABOUT THE PATIENT'S SUDDEN DEATH. THE CAUSE OF DEATH WAS UNKNOWN AND IT WAS UNKNOWN IF THE AUTOPSY WAS PERFORMED OR NOT. THE ADJUDICATION INDICATED POSSIBLE STENT THROMBOSIS.

  Patient problems: Death; Thrombosis

  MAUDE report 8132750 ↗
• DeathAug 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) CLINICAL STUDY. IT WAS REPORTED THAT THE PATIENT DIED. IN (B)(6) 2013, CLINICAL STATUS ASSESSMENT INDICATED THAT THE PATIENT'S QUALIFYING CONDITION WAS STABLE ANGINA. PRIOR TO PROCEDURE, THE PATIENT WAS FOUND TO HAVE EVIDENCES INDICATIVE OF ISCHEMIA AND THE PATIENT WAS REFERRED FOR CARDIAC CATHETERIZATION. SUBSEQUENTLY, THE INDEX PROCEDURE WAS PERFORMED. THE TARGET LESION WAS LOCATED IN THE 1ST OBTUSE MARGINAL (OM) BRANCH WITH 90% STENOSIS AND WAS 15MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.00MM. THE TARGET LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 3.00 X 12MM STUDY STENT FOLLOWED BY POST DILATION AND THE RESIDUAL STENOSIS WAS FOUND TO BE 5%. ON THE NEXT DAY, THE PATIENT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY. IN (B)(6) 2018, THE PATIENT DIED. THE CAUSE OF DEATH HAS BEEN REPORTED AS SUDDEN DEATH.

  Patient problems: Death

  MAUDE report 7802503 ↗
• DeathSep 18, 2017Occlusion Within Device; Adverse Event Without Identified Device or Use Problem; Occlusion Within Device; Adverse Event Without Identified Device or Use Problem

  (B)(6) CLINICAL STUDY. SAME CASE AS: 2134265-2017-09097 AND 2134265-2017-09094. IT WAS REPORTED THAT THE PATIENT EXPIRED. IN (B)(6) 2012 THE PATIENT PRESENTED WITH UNSTABLE ANGINA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. CORONARY ANGIOGRAPHY WAS PERFORMED AND THE PATIENT WAS REFERRED FOR PERCUTANEOUS CORONARY INTERVENTION. TARGET LESION #1 WAS LOCATED IN THE 1ST DIAGONAL WITH 90% STENOSIS AND WAS 10 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.00 MM. TARGET LESION #1 WAS TREATED WITH DIRECT PLACEMENT USING 3.00 MM X 12.00 MM PROMUS ELEMENT¿ PLUS STENT, FOLLOWING POST DILATATION WITH 0% RESIDUAL STENOSIS. TARGET LESION #2 WAS LOCATED IN THE PROXIMAL LCX WITH 90% STENOSIS AND WAS 10 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.7 MM. TARGET LESION #2 WAS TREATED WITH DIRECT STENT PLACEMENT USING A 2.75 MM X 12.00 MM PROMUS ELEMENT¿ PLUS STENT FOLLOWING POST DILATATION WITH 0% RESIDUAL STENOSIS. TARGET LESION #3 WAS LOCATED IN THE DISTAL LCX WITH 60% STENOSIS AND WAS 12 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.00 MM. TARGET LESION #3 WAS TREATED WITH DIRECT STENT PLACEMENT USING A 3.00 X 16.00 MM PROMUS ELEMENT¿ PLUS STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0

  Patient problems: Death; Thrombosis

  MAUDE report 6872473 ↗