PROMUS Element™ Plus H7493911408220Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729807810), received between Feb 27, 2017 and Mar 6, 2018 — classified as 1 death, 1 injury.

The most frequently reported specific device problem is “Occlusion Within Device” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• DeathMar 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SAME CASE AS MDR ID# 2134265-2018-01508 AND 2134265-2018-01510. (B)(6) CLINICAL STUDY. IT WAS REPORTED THAT MYOCARDIAL INFARCTION (MI) OCCURRED AND THE PATIENT DIED. IN (B)(6) 2013, THE PATIENT PRESENTED DUE TO STABLE ANGINA AND WAS REFERRED FOR ELECTIVE CARDIAC CATHETERIZATION. SUBSEQUENTLY, CORONARY ANGIOGRAPHY AND INDEX PROCEDURE WERE PERFORMED. TARGET LESION #1 WAS A DE NOVO LESION LOCATED IN THE DISTAL LEFT ANTERIOR DESCENDING ARTERY WITH 90% STENOSIS AND WAS 15 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.25 MM. TARGET LESION #1 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.25 X 16 MM PROMUS ELEMENT¿ PLUS STENT, WITH 0% RESIDUAL STENOSIS AND TIMI 3 FLOW NOTED. TARGET LESION #2 WAS A DE NOVO LESION LOCATED IN THE RIGHT POSTERIOR DESCENDING ARTERY WITH 90% STENOSIS AND WAS 26 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.25 MM AND WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.25 X 8 MM AND 2.25 X 20 MM PROMUS ELEMENT¿ PLUS STENTS. FOLLOWING POST-DILATATION, RESIDUAL STENOSIS WAS 0% AND TIMI 3 FLOW NOTED. THE FOLLOWING DAY, THE PATIENT WAS DISCHARGED ON ASPIRIN AND TICAGRELOR. IN (B)(6) 2017, THE PATIENT HAD A CARDIAC ARREST WHICH WAS FURTHER DIAGNOSED AS MI. THE

  Patient problems: Death; Myocardial Infarction

  MAUDE report 7318225 ↗
• InjuryFeb 27, 2017Occlusion Within Device; Occlusion Within Device

  SAME CASE AS MDR ID #: 2134265-2017-01572. (B)(6) CLINICAL STUDY. IT WAS REPORTED THAT IN-STENT RESTENOSIS AND CHEST DISCOMFORT OCCURRED. IN (B)(6) 2013, THE PATIENT PRESENTED DUE TO CHEST PAIN AND WAS REFERRED FOR CARDIAC CATHETERIZATION. SUBSEQUENTLY, INDEX PROCEDURE WAS PERFORMED. THE TARGET LESION# 1 WAS A DE NOVO LESION, LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH 95% STENOSIS AND WAS 6 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.25MM. THE LESION WAS TREATED WITH DIRECT STENT PLACEMENT USING 2.25X8MM PROMUS ELEMENT¿ PLUS STENT RESULTING IN 0% STENOSIS. THE TARGET LESION #2 WAS A DE NOVO LESION LOCATED IN THE PROXIMAL LEFT CIRCUMFLEX (LCX) WITH 85% STENOSIS AND WAS 22MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.50 MM. THE LESION WAS TREATED WITH DIRECT STENT PLACEMENT USING 2.50X24MM PROMUS ELEMENT¿ PLUS STENT RESULTING IN 0% STENOSIS. ONE DAY POST PROCEDURE, THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2016, THE PATIENT PRESENTED FOR FOLLOW-UP AND HAD ONGOING SYMPTOMS OF EXERTIONAL AND RESTING CHEST HEAVINESS. THE SYMPTOMS GOT RELIEVED BY NITROGLYCERINE AND THE PATIENT WAS REFERRED FOR CARDIAC CATHETERIZATION. 99% IN-STENT RESTENOSIS OF

  Patient problems: Chest Tightness/Pressure; Reocclusion

  MAUDE report 6362395 ↗