PROMUS Element™ Plus H7493911416250Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729807834), received between Feb 27, 2017 and Apr 18, 2018 — classified as 3 deaths, 1 injury.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• DeathApr 18, 2018Obstruction of Flow; Adverse Event Without Identified Device or Use Problem; Obstruction of Flow; 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 UNSTABLE ANGINA. SUBSEQUENTLY, CORONARY ANGIOGRAPHY AND INDEX PROCEDURE WERE PERFORMED. THE TARGET LESION WAS A DE NOVO LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH 50% STENOSIS AND WAS 12MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5MM. THE LESION WAS TREATED WITH DIRECT PLACEMENT OF A 2.25X16MM PROMUS ELEMENT¿ PLUS DRUG-ELUTING STENT. FOLLOWING POST DILATATION, THE RESIDUAL STENOSIS WAS 0% WITH TIMI 3 FLOW. ON THE FOLLOWING DAY, THE PATIENT WAS DISCHARGED ON ASPIRIN AND TICAGRELOR. IN (B)(6) 2017, THE PATIENT EXPIRED DUE TO UNKNOWN CAUSE OF DEATH.

  Patient problems: Death; Thrombosis

  MAUDE report 7441764 ↗
• DeathMar 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SAME CASE AS MDR ID 2134265-2018-01531. (B)(6) CLINICAL STUDY. IT WAS REPORTED THAT THE PATIENT DIED. IN (B)(6) 2013, THE PATIENT PRESENTED WITH STABLE ANGINA. SUBSEQUENTLY, THE PATIENT WAS REFERRED FOR CARDIAC CATHETERIZATION AND INDEX PROCEDURE WAS PERFORMED. THE TARGET LESION WAS A BIFURCATED, DE NOVO LESION LOCATED IN THE MIDDLE LEFT ANTERIOR DESCENDING (LAD) WITH 95 % STENOSIS AND WAS 12 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.25 MM. THE LESION WAS TREATED WITH A PLACEMENT OF A 2.25 X 16 MM PROMUS ELEMENT¿ PLUS STUDY STENT WITH 5% RESIDUAL STENOSIS. TARGET LESION #2 WAS A DE NOVO LESION LOCATED IN THE PROXIMAL LAD WITH 70 % STENOSIS AND WAS 12 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5 MM. THE LESION WAS TREATED WITH DIRECT PLACEMENT OF 2.50 X 16 MM PROMUS ELEMENT¿ PLUS STUDY STENT WITH 5% RESIDUAL STENOSIS. THE FOLLOWING DAY, THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2017, THE PATIENT WAS TRANSFERRED TO THE STUDY HOSPITAL FOR EVALUATION OF ELEVATED TROPONIN LEVEL (0.990). A DAY PRIOR TO THE TRANSFER TO THE STUDY HOSPITAL THE TROPONIN VALUE WAS REPORTED TO BE 1.010. THE PATIENT WAS HOSPITALIZED ON THE SAME DAY AND WAS DIAGNOSED WITH ATRIAL FIB

  Patient problems: Atrial Fibrillation; Death

  MAUDE report 7314420 ↗
• InjuryJan 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) CLINICAL STUDY. IT WAS REPORTED THAT MYOCARDIAL INFARCTION AND RESTENOSIS OCCURRED. IN (B)(6) 2012, THE SUBJECT PRESENTED WITH UNSTABLE ANGINA (BRAUNWALD CLASSIFICATION: IIB) AND WAS REFERRED FOR CARDIAC CATHETERIZATION. TARGET LESION #1 WAS A DE NOVO LESION LOCATED IN MID RIGHT CORONARY ARTERY (RCA) EXTENDED TO DISTAL RCA WITH 75% STENOSIS AND WAS 58 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.0 MM. TARGET LESION #1 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF 2.75 MM X 38 MM AND 2.75 MM X 24 MM PROMUS ELEMENT PLUS STENTS IN AN OVERLAPPING FASHION. FOLLOWING POST DILATATION RESIDUAL STENOSIS WAS 25%. TARGET LESION #2 WAS A DE NOVO LESION LOCATED IN THE RIGHT POSTERIOR DESCENDING ARTERY (R-PDA) WITH 75% STENOSIS AND WAS 12 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5 MM. TARGET LESION #2 WAS TREATED WITH DIRECT PLACEMENT OF A 2.50 MM X 16 MM PROMUS ELEMENT PLUS STENT. FOLLOWING POST DILATATION RESIDUAL STENOSIS WAS 25%. THE SUBJECT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2017, THE SUBJECT PRESENTED WITH THE COMPLAINTS OF CHEST PAIN ASSOCIATED WITH SHORTNESS OF BREATH AND WAS HOSPITALIZED ON THE SAME DAY. CHEST X RAY REVEALED INTERSTITIAL THICKENING WITH

  Patient problems: Cardiac Enzyme Elevation; Chest Pain; Dyspnea; Myocardial Infarction; Reocclusion; Tachycardia

  MAUDE report 7211538 ↗
• DeathFeb 27, 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. IT WAS REPORTED THAT THE PATIENT DIED. IN (B)(6) 2013, THE PATIENT WAS DIAGNOSED WITH UNSTABLE ANGINA. SUBSEQUENTLY, CORONARY ANGIOGRAPHY AND INDEX PROCEDURE WERE PERFORMED. THE TARGET LESION WAS A DE NOVO LESION LOCATED IN THE FIRST DIAGONAL WITH 85% STENOSIS AND WAS 12 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5 MM. THE LESION WAS TREATED BY DIRECT PLACEMENT OF A 2.50 X 16 MM PROMUS ELEMENT¿ PLUS STUDY STENT. FOLLOWING POST-DILATATION, RESIDUAL STENOSIS WAS 0%. ONE DAY POST PROCEDURE, THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2017, THE PATIENT DIED.

  Patient problems: Death; Thrombosis

  MAUDE report 6361492 ↗