PROMUS Element™ Plus H7493911412250Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729807827), received between Mar 17, 2017 and Jul 27, 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.

• InjuryJul 27, 2018Obstruction of Flow; Obstruction of Flow

  (B)(6) CLINICAL STUDY. IT WAS REPORTED THAT PATIENT EXPERIENCED UNSTABLE ANGINA AND IN-STENT RESTENOSIS OCCURRED. IN (B)(6) 2013, CLINICAL STATUS ASSESSMENT INDICATED THAT THE PATIENT'S QUALIFYING CONDITION WAS STABLE ANGINA. PRIOR TO PROCEDURE, THE PATIENT WAS INDICATIVE OF ISCHEMIA AND THE PATIENT WAS REFERRED FOR ELECTIVE CARDIAC CATHETERIZATION. SUBSEQUENTLY, CORONARY ANGIOGRAPHY AND THE INDEX PROCEDURE WERE PERFORMED. THE TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH 90% STENOSIS AND WAS 8MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5MM. TARGET LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.50X12MM STUDY STENT. FOLLOWING POST- DILATION, THE RESIDUAL STENOSIS WAS 0%. ON THE NEXT DAY, THE PATIENT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY. IN (B)(6) 2017, THE PATIENT PRESENTED WITH COMPLAINTS OF CHEST PAIN. THE PATIENT WAS RECOMMENDED FOR A CARDIAC CATHETERIZATION ON A LATER DATE AND WAS ADVISED TO TAKE SUBLINGUAL NITROGLYCERIN IN CASE OF RECURRENT ACUTE CHEST PAIN. THREE DAYS AFTER, THE PATIENT PRESENTED FOR THE EVALUATION OF CHEST PAIN AND WAS HOSPITALIZED ON THE SAME DAY. THE 70-80% TUBULAR STENOSIS IN MID LAD AND 80% IN-STENT

  Patient problems: Angina; Reocclusion

  MAUDE report 7726672 ↗
• DeathMay 10, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SAME CASE AS MDR ID #: 2134265-2017-04403 AND 2134265-2017-04404. IT WAS REPORTED THAT MYOCARDIAL INFARCTION OCCURRED AND THE PATIENT DIED. IN (B)(6) 2013, THE PATIENT PRESENTED DUE TO MYOCARDIAL INFARCTION (MI) AND WAS FURTHER REFERRED FOR CARDIAC CATHETERIZATION. TWO DAYS AFTER, THE INDEX PROCEDURE WAS PERFORMED. THE TARGET LESION WAS A DE NOVO LOCATED IN THE DISTAL LEFT CIRCUMFLEX (LCX) ARTERY WITH 80% STENOSIS AND WAS 32MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.75MM. THE TARGET LESION WAS TREATED WITH PRE-DILATATION AND 2 PROMUS ELEMENT¿ PLUS DRUG-ELUTING STENTS OF 2.50MM X 12MM AND ANOTHER PROMUS ELEMENT¿ PLUS DRUG-ELUTING STENT OF 2.75MM X 16MM WERE SUCCESSFULLY DEPLOYED. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. EIGHT DAYS AFTER, THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2016, PATIENT PRESENTED TO HOSPITAL WITH CHEST PAIN AND PERSISTENT PURULENT DRAINAGE FROM THE UPPER EXTREMITY. PATIENT WAS HOSPITALIZED ON THE SAME DAY. PATIENT WAS PLACED ON A HEPARIN DRIP TO TREAT CHEST PAIN. TWO DAYS AFTER, PATIENT WAS STABLE AND TAKEN TO DIALYSIS. TWO DAYS LATER, PATIENT WAS WEAK AND REFUSED HEMODIALYSIS. AS THE PATIENT WAS STILL WEAK AND HAD ELEVATE

  Patient problems: Death; Myocardial Infarction

  MAUDE report 6559094 ↗
• DeathMay 10, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SAME CASE AS MDR ID #: 2134265-2017-04402 AND 2134265-2017-04404. IT WAS REPORTED THAT MYOCARDIAL INFARCTION OCCURRED AND THE PATIENT DIED. IN (B)(6) 2013, THE PATIENT PRESENTED DUE TO MYOCARDIAL INFARCTION (MI) AND WAS FURTHER REFERRED FOR CARDIAC CATHETERIZATION. TWO DAYS AFTER, THE INDEX PROCEDURE WAS PERFORMED. THE TARGET LESION WAS A DE NOVO LOCATED IN THE DISTAL LEFT CIRCUMFLEX (LCX) ARTERY WITH 80% STENOSIS AND WAS 32MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.75MM. THE TARGET LESION WAS TREATED WITH PRE-DILATATION AND 2 PROMUS ELEMENT¿ PLUS DRUG-ELUTING STENTS OF 2.50MM X 12MM AND ANOTHER PROMUS ELEMENT¿ PLUS DRUG-ELUTING STENT OF 2.75MM X 16MM WERE SUCCESSFULLY DEPLOYED. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. EIGHT DAYS AFTER, THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2016, PATIENT PRESENTED TO HOSPITAL WITH CHEST PAIN AND PERSISTENT PURULENT DRAINAGE FROM THE UPPER EXTREMITY. PATIENT WAS HOSPITALIZED ON THE SAME DAY. PATIENT WAS PLACED ON A HEPARIN DRIP TO TREAT CHEST PAIN. TWO DAYS AFTER, PATIENT WAS STABLE AND TAKEN TO DIALYSIS. TWO DAYS LATER, PATIENT WAS WEAK AND REFUSED HEMODIALYSIS. AS THE PATIENT WAS STILL WEAK AND HAD ELEVATE

  Patient problems: Death; Myocardial Infarction

  MAUDE report 6559079 ↗
• 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 6414424 ↗