PROMUS Element™ Plus H7493911420300Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08714729807964), received between Mar 17, 2017 and Oct 26, 2018 — classified as 5 deaths, 3 injuries.

The most frequently reported specific device problem is “Occlusion Within Device” (4 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 8 most recent of 8 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 8009668 ↗
• DeathApr 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 MYOCARDIAL INFARCTION OCCURRED AND THE PATIENT DIED. IN (B)(6) 2013, THE PATIENT PRESENTED WITH STABLE ANGINA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. THE TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH 75% STENOSIS AND WAS 12 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.0 MM. THE LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 3.00 X 20 MM STUDY STENT AND THE RESIDUAL STENOSIS WAS 0%. ONE DAY POST PROCEDURE, THE PATIENT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY. IN (B)(6) 2018, THE PATIENT PRESENTED WITH THE COMPLAINTS OF SHORTNESS OF BREATH FOR TWO WEEKS AND WAS HOSPITALIZED ON THE SAME DAY. CARDIAC ENZYMES WERE FOUND TO BE ELEVATED. ELECTROCARDIOGRAM (ECG) REVEALED A-V BLOCK, WIDE QRS INTERVALS WITH LEFT BUNDLE BRANCH BLOCK AND CT REVEALED PULMONARY EDEMA AND BILATERAL EFFUSIONS. CHEST X-RAY REVEALED BILATERAL PLEURAL EFFUSION AND BASILAR AIRSPACE DISEASE WITH STABLE HILAR AND PERIHILAR OPACITIES. THE PATIENT WAS DIAGNOSED WITH ACUTE ON CHRONIC COMBINED SYSTOLIC AND DIASTOLIC CONGESTIVE HEART FAILURE (CHF), ACUTE HYPOXIC RESPIRATORY FAILURE AND PULMONARY EDEMA. THE PATIENT WAS PLACED ON

  Patient problems: Death; Dyspnea; Myocardial Infarction

  MAUDE report 7465800 ↗
• DeathJan 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) CLINICAL STUDY. SAME CASE AS MFR REPORT#: 2134265-2018-00107. IT WAS REPORTED THAT POST A CORONARY ARTERY DRUG ELUTING STENTING TREATMENT PROCEDURE, THE PATIENT HAD CARDIAC ARREST AND EXPIRED. IN (B)(6) 2013, THE PATIENT PRESENTED DUE TO UNSTABLE ANGINA (BRAUNWALD CLASSIFICATION: IIIB) AND MYOCARDIAL INFARCTION AND WAS REFERRED FOR CARDIAC CATHETERIZATION. THE FIRST TARGET LESION WAS A DE NOVO LESION LOCATED IN THE 1ST OBTUSE MARGINAL BRANCH (OM1) WITH 80% STENOSIS AND WAS 20 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5 MM. IT WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.50 X 28 MM PROMUS ELEMENT PLUS STENT, WITH 0% RESIDUAL STENOSIS AND TIMI 3 FLOW. THE SECOND TARGET LESION WAS A BIFURCATED DE NOVO LESION LOCATED IN THE LEFT MAIN CORONARY ARTERY (LMCA) WITH 60% STENOSIS AND WAS 15 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.0 MM. IT WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 3.00 X 20 MM PROMUS ELEMENT PLUS STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0% AND TIMI 3 FLOW. THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL THE NEXT DAY. IN (B)(6) 2017, THE PATIENT WAS HOSPITALIZED DUE TO CARDIAC ARREST. THE PATIENT EXPIRED FOUR DAYS LATER AN

  Patient problems: Cardiac Arrest; Death; Hypoxia

  MAUDE report 7221264 ↗
• InjuryJan 24, 2018Occlusion Within Device; Occlusion Within Device

  (B)(4) CLINICAL STUDY. IT WAS REPORTED THAT POST A CORONARY ARTERY DRUG ELUTING STENTING TREATMENT PROCEDURE, IN-STENT RESTENOSIS OCCURRED AND THE PATIENT HAD ANGINA. IN (B)(6) 2013, CLINICAL STATUS ASSESSMENT IDENTIFIED THAT THE PATIENT¿S QUALIFYING CONDITION AS STABLE ANGINA (CCS CLASSIFICATION 2). PRIOR TO PROCEDURE, THE PATIENT WAS NOTED TO HAVE ABNORMAL STRESS TEST OR IMAGING STRESS TEST INDICATIVE OF ISCHEMIA AND THE PATIENT WAS REFERRED FOR ELECTIVE CARDIAC CATHETERIZATION. THE TARGET LESION WAS LOCATED IN THE 1ST OBTUSE MARGINAL BRANCH (OM1) WITH 95% STENOSIS AND WAS 15 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.75 MM. THE TARGET LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 3.0 X 20 MM STUDY STENT WITH 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY THE NEXT DAY. IN (B)(6) 2017, THE PATIENT PRESENTED TO HOSPITAL WITH THE COMPLAINTS OF CHEST PAIN AND HAD STRESS TEST DONE. THE PATIENT WAS DIAGNOSED WITH UNSTABLE ANGINA. SUBSEQUENTLY, THE SUBJECT WAS HOSPITALIZED AND WAS REFERRED FOR CARDIAC CATHETERIZATION. THE 95% IN-STENT RESTENOSIS OF STUDY STENT DEPLOYED IN OM1 AND 90% STENOSIS IN PROXIMAL OM WAS NOTED AND TREATED WITH PLACEME

  Patient problems: Angina; Reocclusion

  MAUDE report 7215874 ↗
• DeathOct 9, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) CLINICAL STUDY. IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY DRUG ELUTING STENTING TREATMENT PROCEDURE, THE PATIENT EXPIRED. IN (B)(6) 2012, THE PATIENT WAS DIAGNOSED WITH UNSTABLE ANGINA (BRAUNWALD CLASSIFICATION: IIIC) ALONG WITH MYOCARDIAL INFARCTION AND WAS REFERRED FOR CARDIAC CATHETERIZATION. THE TARGET LESION WAS LOCATED IN THE PROXIMAL TO MID LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH 80% IN-STENT RESTENOSIS OF AN UNKNOWN STENT AND WAS 20MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.00MM. THE TARGET LESION WAS TREATED WITH DIRECT PLACEMENT OF A 3.00X20MM PROMUS ELEMENT PLUS STENT, WITH 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL THE NEXT DAY. IN (B)(6) 2017, THE PATIENT EXPIRED. THE IMMEDIATE CAUSE OF DEATH IS UNKNOWN.

  Patient problems: Death

  MAUDE report 6930213 ↗
• InjuryOct 5, 2017Occlusion Within Device; Occlusion Within Device

  (B)(4) CLINICAL STUDY. IT WAS REPORTED THAT IN-STENT RESTENOSIS (ISR) AND TARGET VESSEL REVASCULARIZATION (TVR) OCCURRED. IN (B)(6) 2013, THE PATIENT¿S QUALIFYING CONDITION WAS STABLE ANGINA. PRIOR TO THE PROCEDURE, THE PATIENT WAS ALSO FOUND TO HAVE OTHER OBJECTIVE EVIDENCE OF ISCHEMIA AND THE PATIENT WAS REFERRED FOR CARDIAC CATHETERIZATION. SUBSEQUENTLY, INDEX PROCEDURE WAS PERFORMED. THE TARGET LESION WAS LOCATED IN DISTAL LEFT CIRCUMFLEX (LCX)/MID LCX WITH 80% STENOSIS, AND WAS 14 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3 MM. THE LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 3.00 X 20 MM STUDY STENT WITH 0% RESIDUAL STENOSIS. ONE DAY POST PROCEDURE, THE PATIENT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY. IN (B)(6) 2016, THE PATIENT PRESENTED WITH COMPLAINTS OF EXERTIONAL CHEST PAIN AND WAS HOSPITALIZED ON THE SAME DAY. SUBSEQUENTLY, THE SUBJECT WAS REFERRED TO CARDIAC CATHETERIZATION. PATIENT¿S CORONARY ANGIOGRAPHY REVEALED 80% STENOSIS LOCATED IN THE PROXIMAL LCX AND WAS TREATED WITH THE DEPLOYMENT OF 3.5 X 12MM SYNERGY DRUG-ELUTING STENT IN AN OVERLAPPING MANNER WITH THE PREVIOUSLY PLACED STENTS WITH 0% RESIDUAL STENOSIS AND TIMI 3 FLOW.

  Patient problems: Chest Pain; Reocclusion

  MAUDE report 6914975 ↗
• 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# 2134265-2017-03331 AND 2134265-2017-03332. (B)(6) 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 6479614 ↗
• DeathMar 17, 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 PER ADJUDICATION RESULTS THAT STENT THROMBOSIS (ST) OCCURRED.

  Patient problems: Cardiac Arrest; Death; Thrombosis

  MAUDE report 6413134 ↗