PROMUS Element™ Plus H7493911420350Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729808022), received between Feb 16, 2017 and Sep 5, 2018 — classified as 1 death, 2 injuries.

The most frequently reported specific device problem is “Occlusion Within Device” (2 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.

• InjurySep 5, 2018Obstruction of Flow; Obstruction of Flow

  (B)(6) CLINICAL STUDY. IT WAS REPORTED THAT UNSTABLE ANGINA AND IN-STENT RESTENOSIS (ISR) OCCURRED. IN (B)(6) 2013, THE PATIENT'S QUALIFYING CONDITION WAS UNSTABLE ANGINA. PRIOR TO PROCEDURE, THE PATIENT WAS FOUND TO HAVE ABNORMAL STRESS TEST OR IMAGING STRESS TEST INDICATIVE OF ISCHEMIA AND THE SUBJECT WAS REFERRED FOR CARDIAC CATHETERIZATION. THE INDEX PROCEDURE WAS PERFORMED ON THE SAME DAY. THE TARGET LESION WAS LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) WITH 95% STENOSIS AND WAS 15 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.5 MM. THE TARGET LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 3.50X20MM STENT, FOLLOWING POST DILATION THE RESIDUAL STENOSIS WAS 0%. THE FOLLOWING DAY, THE PATIENT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY. IN (B)(6) 2018, THE PATIENT HAD PRESENTED FOR CARDIOVASCULAR CONSULTATION WITH THE COMPLAINT OF CHEST PAIN, SHORTNESS OF BREATH AND CHEST DISCOMFORT. THE PATIENT WAS REFERRED FOR CORONARY ANGIOGRAPHY FOR FURTHER EVALUATION AND MANAGEMENT. SEVEN DAYS LATER CORONARY ANGIOGRAPHY REVEALED 20% IN-STENT RESTENOSIS OF THE PREVIOUSLY PLACED STUDY STENT IN PROXIMAL PORTION, MINOR PLAQUING IN MID AND DISTAL PORTION; MINOR PLAQUING IN POS

  Patient problems: Angina; Obstruction/Occlusion; Reocclusion

  MAUDE report 7847957 ↗
• DeathApr 11, 2017Occlusion 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# 2134265-2017-03330 AND 2134265-2017-03331. IT WAS REPORTED THAT THE PATIENT DIED. IN (B)(6) 2013, THE PATIENT'S QUALIFYING CONDITION WAS UNSTABLE ANGINA. PRIOR TO PROCEDURE, THE PATIENT WAS FOUND TO HAVE ABNORMAL FRACTIONAL FLOW RESERVE INDICATIVE OF ISCHEMIA AND THE PATIENT WAS REFERRED FOR CARDIAC CATHETERIZATION. ON THE SAME DAY, THE INDEX PROCEDURE WAS PERFORMED. TARGET LESION #1 WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH 70% STENOSIS AND WAS 16 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.00 MM. TARGET LESION #1 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF 3.00X20MM STUDY STENT. FOLLOWING POST-DILATATION, RESIDUAL STENOSIS WAS 0%. TARGET LESION #2 WAS LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA) WITH 65% STENOSIS AND WAS 10 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.5 MM. TARGET LESION #2 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF 3.50X12MM STUDY STENT. FOLLOWING POST-DILATATION, RESIDUAL STENOSIS WAS 0%. TARGET LESION #3 WAS LOCATED IN THE PROXIMAL RCA WITH 75% STENOSIS AND WAS 12 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.5 MM. TARGET LESION #3 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF 3.50X20MM STUDY STENT.

  Patient problems: Death; Sudden Cardiac Death; Thrombosis

  MAUDE report 6479512 ↗
• InjuryFeb 16, 2017Occlusion Within Device; Occlusion Within Device

  (B)(6) CLINICAL STUDY. IT WAS REPORTED THAT MYOCARDIAL INFARCTION AND IN-STENT RESTENOSIS OCCURRED. IN (B)(6) 2013, CLINICAL STATUS ASSESSMENT IDENTIFIED THE PATIENT'S QUALIFYING CONDITION AS ISCHEMIA AND STABLE ANGINA. SUBSEQUENTLY, CORONARY ANGIOGRAPHY AND INDEX PROCEDURE WERE PERFORMED. THE TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) WITH 90% STENOSIS, A LENGTH OF 16 MM AND A REFERENCE VESSEL DIAMETER OF 3.5 MM. THE LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 3.50 X 20 MM STUDY STENT. FOLLOWING POST-DILATATION, RESIDUAL STENOSIS WAS 0%. ONE DAY POST PROCEDURE, THE PATIENT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY. IN (B)(6) 2016, THE PATIENT DEVELOPED CHEST PAIN RADIATING TO THE LEFT ARM AND NECK. IN ADDITION, THE PATIENT ALSO HAD DYSPNEIC SYMPTOMS AND ORTHOPNEA. THE FOLLOWING DAY, PATIENT WAS PRESENTED TO NON STUDY HOSPITAL WITH COMPLAINTS OF CHEST PAIN WHICH GOT RESOLVED EARLY IN THE MORNING AND DYSPNEA ON EXERTION. PATIENT WAS HOSPITALIZED FOR THE SAME. AN ELECTROCARDIOGRAM (ECG) WAS PERFORMED, WHICH REVEALED ATRIAL FIBRILLATION WITH COMPLETE RIGHT BUNDLE BRANCH BLOCK. CHEST X-RAY WAS PERFORMED, WHICH REVEALED AN ENLARGED HEART. ECHOCAR

  Patient problems: Atrial Fibrillation; Cardiac Enzyme Elevation; Chest Pain; Dyspnea; Myocardial Infarction; Reocclusion

  MAUDE report 6336235 ↗