PROMUS Element™ Plus H7493911416300Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729807957), received between Dec 16, 2016 and Feb 14, 2018 — classified as 4 deaths, 1 injury.

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.

• DeathFeb 14, 2018Occlusion 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 UNSTABLE ANGINA (BRAUNWALD CLASSIFICATION: IIIB). SUBSEQUENTLY, THE PATIENT WAS REFERRED FOR CARDIAC CATHETERIZATION AND THE INDEX PROCEDURE WAS PERFORMED ON THE SAME DAY. THE TARGET LESION# 1 WAS A DE NOVO LESION LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY WITH 75% STENOSIS AND WAS 10MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3. 50 MM. THE LESION WAS TREATED WITH DIRECT PLACEMENT OF 3.00X16MM PROMUS ELEMENT¿ PLUS DRUG-ELUTING 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 EXPIRED. PER DEATH CERTIFICATE, THE PATIENT DIED DUE TO ATHEROSCLEROTIC HEART DISEASE. THE OTHER SIGNIFICANT CONDITIONS CONTRIBUTING TO THE DEATH OF THE PATIENT WERE CONGESTIVE HEART FAILURE, ATRIAL FIBRILLATION AND HYPERTENSION. AUTOPSY WAS NOT PERFORMED.

  Patient problems: Death; Thrombosis

  MAUDE report 7271892 ↗
• 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: 2134265-2017-09093 AND 2134265-2017-09097. 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 6872457 ↗
• 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 THAT STENT THROMBOSIS OCCURRED AS PER THE ACADEMIC RESEARCH CONSORTIUM DEFINITIONS.

  Patient problems: Death; High Blood Pressure/ Hypertension; Myocardial Infarction; Thrombosis

  MAUDE report 6414403 ↗
• InjuryMar 17, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT THE STUDY STENT IN THE PROXIMAL LAD WAS PATENT. THEREFORE, THE EVENTS OCCURRED ARE NOT RELATED TO THE STUDY DEVICE.

  Patient problems: Chest Pain; Myocardial Infarction

  MAUDE report 6414342 ↗
• 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 6181459 ↗