PROMUS Element™ Plus H7493911438270Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729823742), received between Dec 6, 2016 and Apr 18, 2018 — classified as 2 deaths, 1 injury.

The most frequently reported specific device problem is “Occlusion Within Device” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 18, 2018Occlusion Within Device; Occlusion Within Device

  (B)(6) CLINICAL STUDY. IT WAS REPORTED THAT CHEST PAIN AND IN-STENT RESTENOSIS (ISR) OCCURRED. IN (B)(6) 2013, THE PATIENT PRESENTED DUE TO UNSTABLE ANGINA. 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 LONG LESION LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) AND EXTENDING TO MID RCA, WITH 90% STENOSIS AND WAS 38 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.00 MM. THE LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.75 X 38 MM PROMUS ELEMENT¿ PLUS DRUG-ELUTING STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. IN (B)(6) 2018, THE PATIENT PRESENTED WITH CHEST PAIN AND LOWER BACK PAIN AND DESCRIBES THE PAIN AS SHARP AND ACROSS CHEST. THE PATIENT REPORTED TO BE FALLING SHORT OF BREATH WHILE TALKING AND RATED THE PAIN TO BE 7-8 OUT OF 10 IN TERMS OF SEVERITY. THE SUBJECT IS ON HYDROCODONE WHICH HELPS TO DECREASE THE PAIN. THE ELECTROCARDIOGRAM REVEALED NORMAL SINUS RHYTHM WITH T WAVE INVERSION IN V5 AND V6. CHEST X-RAY DEMONSTRATED NO EVIDENCE OF ACUTE CARDIOPULMONARY DISEASE. POST ASSESSMENT, THE PATIENT WAS NOTED TO HAVE AN ELEVATED D-DIMER AND R

  Patient problems: Chest Pain; Reocclusion

  MAUDE report 7441371 ↗
• DeathSep 21, 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 EXPIRED. IN (B)(6) 2012, THE PATIENT WAS DIAGNOSED WITH UNSTABLE ANGINA ALONG WITH SILENT ISCHEMIA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. TARGET LESION #1 WAS A DE NOVO LESION LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY (CASS SITE # 12) WITH 70% STENOSIS AND WAS 28 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.75 MM. TARGET LESION #1 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.75 X 38 MM PROMUS ELEMENT¿ PLUS STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY ON ASPIRIN AND CLOPIDOGREL. HOWEVER, IN (B)(6) OF 2016 THE PATIENT EXPIRED. THE CAUSE OF DEATH IS UNKNOWN.

  Patient problems: Death; Thrombosis

  MAUDE report 6883815 ↗
• DeathDec 6, 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 STENT THROMBOSIS OCCURRED AS PER ADJUDICATION.

  Patient problems: Death; Thrombosis

  MAUDE report 6149627 ↗