PROMUS Element™ Plus H7493911428250Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729807865), received between Dec 6, 2016 and Dec 4, 2017 — classified as 3 deaths, 2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• DeathDec 4, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SAME CASE AS MDR# 2134265-2017-11783 AND 2134265-2017-11784. (B)(6). IT WAS REPORTED THAT THE PATIENT DIED. IN (B)(6) 2012, THE PATIENT WAS REFERRED FOR CARDIAC CATHETERIZATION. SUBSEQUENTLY, INDEX PROCEDURE WAS PERFORMED. THE TARGET LESION #1 WAS A DE NOVO LESION WHICH WAS TOTAL CHRONIC OCCLUSION LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH 100% STENOSIS AND WAS 28MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.00MM. TARGET LESION #1 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.75X28MM STUDY STENT (DES). FOLLOWING POST DILATATION THERE WAS 0 % RESIDUAL STENOSIS. THE TARGET LESION #2 WAS A DE NOVO LESION LOCATED IN THE MID LAD WITH 80% STENOSIS AND WAS 50MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.25MM. TARGET LESION #2 WAS TREATED WITH PRE-DILATATION AND STENT PLACEMENT USING A 2.25X24.00MM STUDY STENT AND A 2.25X28.00 STUDY STENT. FOLLOWING POST-DILATATION, RESIDUAL STENOSIS WAS 0%. THE FOLLOWING DAY, THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2017, THE PATIENT PRESENTED TO THE HOSPITAL WITH COMPLAINTS OF PALPITATIONS WITH SHORTNESS OF BREATH, CHEST HEAVINESS ALONG WITH COUGH. THE PATIENT REPORTED THAT THESE SYMPTOMS STARTED A W

  Patient problems: Arrhythmia; Congestive Heart Failure; Death; Dyspnea; Low Blood Pressure/ Hypotension

  MAUDE report 7079026 ↗
• DeathJun 9, 2017Occlusion Within Device; Adverse Event Without Identified Device or Use Problem; Occlusion Within Device; Adverse Event Without Identified Device or Use Problem

  (B)(6) STUDY. IT WAS REPORTED THAT THE PATIENT DIED. IN (B)(6) 2013, THE PATIENT'S QUALIFYING CONDITION WAS STABLE ANGINA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. SUBSEQUENTLY, INDEX PROCEDURE WAS PERFORMED ON THE SAME DAY. THE TARGET LESION WAS LOCATED IN THE DISTAL LEFT CIRCUMFLEX ARTERY (LCX) WITH 80% STENOSIS AND WAS 28 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.50 MM. THE LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.50 X 28 MM STUDY STENT WITH 10% RESIDUAL STENOSIS. ON THE FOLLOWING DAY, THE PATIENT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY. IN (B)(6) 2016, THE PATIENT EXPIRED AT 12:21 AM DUE TO UNKNOWN CAUSE.

  Patient problems: Death; Thrombosis

  MAUDE report 6630618 ↗
• InjuryMar 29, 2017Occlusion Within Device; Occlusion Within Device

  IT WAS FURTHER REPORTED THAT STENT THROMBOSIS OCCURRED AS PER ADJUDICATION RESULTS.

  Patient problems: Chest Pain; Myocardial Infarction; Reocclusion; ST Segment Elevation; Thrombosis; Ventricular Fibrillation

  MAUDE report 6442301 ↗
• DeathDec 16, 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 DURING THE INDEX PROCEDURE, PRE-DILATATION WAS PERFORMED IN THE LEFT MAIN CORONARY ARTERY. AS PER DEATH CERTIFICATE, THE IMMEDIATE CAUSE OF DEATH WAS "CORONARY ARTERY DISEASE" AND THE SEQUENTIAL CONTRIBUTING CAUSE OF DEATH WAS "CONGESTIVE HEART FAILURE". ALSO, ADJUDICATION INDICATES STENT THROMBOSIS OCCURRED.

  Patient problems: Congestive Heart Failure; Death; Thrombosis

  MAUDE report 6181499 ↗
• InjuryDec 6, 2016Occlusion 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: 2134265-2016-11216. (B)(4). IT WAS REPORTED THAT IN-STENT RESTENOSIS (ISR) AND MYOCARDIAL INFARCTION (MI) OCCURRED. IN (B)(6) 2012, THE PATIENT PRESENTED WITH UNSTABLE ANGINA AND INDEX PROCEDURE WAS PERFORMED ON THE SAME DAY. THE TARGET LESION WAS DE NOVO LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH 70 % STENOSIS AND WAS 45 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5 MM. THE TARGET LESION WAS TREATED WITH DIRECT PLACEMENT OF A 2.50 MM X 28 MM AND 2.75 X 20 MM PE PLUS STENTS. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. THE PATIENT HAD SIGNIFICANT ANGINA AND HAD REPRODUCIBLE ANGINA WITH BALLOON OCCLUSION DURING LAD STENTING. THE MID LAD STENOSIS WAS LIKELY CULPRIT FOR ANGINA. SUBSEQUENTLY, THE PROXIMAL SEGMENT OF DIAGONAL ARTERY WAS ANGIOPLASTIED USING 1.5 X 1.5 MM APEX BALLOON CATHETER. AFTER 2 DAYS, THE PATIENT WAS DISCHARGED WITH ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2016, THE PATIENT WAS DIAGNOSED WITH ACUTE DECOMPENSATED SYSTOLIC HEART FAILURE AND THE PATIENT WAS HOSPITALIZED ON THE SAME DAY. THE PATIENT RECEIVED MEDICATION THERAPY IN RESPONSE TO THE EVENT. SIX DAYS POST-ADMISSION, OUTCOME OF THE EVENT WAS CONSIDERED AS RESO

  Patient problems: Angina; Cardiac Enzyme Elevation; Congestive Heart Failure; Dyspnea; Myocardial Infarction; Non specific EKG/ECG Changes; Reocclusion

  MAUDE report 6149483 ↗