PROMUS Element™ Plus H7493911428270Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729807926), received between Feb 1, 2017 and Dec 4, 2017 — classified as 1 death, 2 injuries.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• DeathDec 4, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SAME CASE AS MDR# 2134265-2017-11784 AND 2134265-2017-11785. (B)(6) CLINICAL STUDY. IT WAS REPORTED THAT THE PATIENT DIED. IN (B)(6) 2012, THE PATIENT WAS REFERRED FOR CARDIAC CATHETERIZATION. SUBSEQUENTLY, INDEX PROCEDURE WAS PERFORMED. THE TARGET LESION #1 WAS A DE NOVO LESION WHICH WAS TOTAL CHRONIC OCCLUSION LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH 100% STENOSIS AND WAS 28 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.00 MM. TARGET LESION #1 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.75 X 28 MM STUDY STENT (DES). FOLLOWING POST DILATATION THERE WAS 0 % RESIDUAL STENOSIS. THE TARGET LESION #2 WAS A DE NOVO LESION LOCATED IN THE MID LAD WITH 80% STENOSIS AND WAS 50 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.25 MM. TARGET LESION #2 WAS TREATED WITH PRE-DILATATION AND STENT PLACEMENT USING A 2.25 X 24.00 MM STUDY STENT AND A 2.25 X 28.00 STUDY STENT. FOLLOWING POST-DILATATION, RESIDUAL STENOSIS WAS 0%. THE FOLLOWING DAY, THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2017, THE PATIENT PRESENTED TO THE HOSPITAL WITH COMPLAINTS OF PALPITATIONS WITH SHORTNESS OF BREATH, CHEST HEAVINESS ALONG WITH COUGH. THE PATIENT REPORTED THAT

  Patient problems: Arrhythmia; Congestive Heart Failure; Death; Dyspnea; Low Blood Pressure/ Hypotension

  MAUDE report 7079019 ↗
• InjuryAug 16, 2017Occlusion Within Device; Occlusion Within Device

  (B)(4) CLINICAL STUDY. IT WAS REPORTED THAT IN-STENT RESTENOSIS (ISR) OCCURRED. IN (B)(6) 2012, THE PATIENT WAS REFERRED FOR CARDIAC CATHETERIZATION. SUBSEQUENTLY, INDEX PROCEDURE WAS PERFORMED. THE TARGET LESION #1 WAS A DE NOVO LESION LOCATED IN FIRST DIAGONAL BRANCH WITH 90% STENOSIS AND WAS 20MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.25MM. THE LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF 2.25X28MM PROMUS ELEMENT¿ PLUS DRUG-ELUTING STENT. FOLLOWING POST-DILATATION, RESIDUAL STENOSIS WAS 0%. THE TARGET LESION #2 WAS A DE NOVO LESION LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH 60% STENOSIS AND WAS 20MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.75MM. THE LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.75X28MM PROMUS ELEMENT¿ PLUS DRUG-ELUTING STENT. FOLLOWING POST-DILATATION, THE RESIDUAL STENOSIS WAS 0%. ONE DAY POST PROCEDURE, THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2012, THE PATIENT WAS HOSPITALIZED FOR STAGED PERCUTANEOUS CORONARY INTERVENTION (PCI) OF THE LEFT CIRCUMFLEX (LCX) AND PROXIMAL LAD. PATIENT¿S CORONARY ANGIOGRAPHY REVEALED WITH 80% PROXIMAL STENOSIS. SUBSEQUENTLY, THE 80% ISR AT THE PROXIMAL

  Patient problems: Angina; Reocclusion

  MAUDE report 6798598 ↗
• InjuryFeb 1, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6). IT WAS REPORTED THAT MYOCARDIAL INFARCTION OCCURRED. IN (B)(6) 2012, CORONARY ANGIOGRAPHY AND INDEX PROCEDURE WERE PREFORMED. THE TARGET LESION WAS A DE NOVO LESION LOCATED IN THE DISTAL RIGHT CORONARY ARTERY (RCA) WITH 80% STENOSIS AND WAS 20MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.25MM. THE LESION WAS TREATED WITH PLACEMENT OF A 2.75X28MM PROMUS ELEMENT¿ PLUS DRUG-ELUTING STENT. FOLLOWING POST-DILATATION, RESIDUAL STENOSIS WAS 0%. ONE DAY POST PROCEDURE, THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL. IN (B)(6) 2016, THE PATIENT PRESENTED TO THE HOSPITAL WITH SEVERE CHEST PAIN. CARDIAC ENZYME VALUES WERE NOTED TO BE ELEVATED (PEAK CK TOTAL = 2950 IU/L, ULN = 174 IU/L; PEAK CK-MB = 357.3 NG/ML, ULN =5.0 NG/ML; PEAK TROPONIN T = 36.58 NG/ML, ULN = 0.1 NG/ML) AND SITE REPORTED AN EVENT OF ACUTE INFEROLATERAL MYOCARDIAL INFARCTION. EKG REVEALED DIFFUSE ST DEPRESSION WITH ST ELEVATION AND AVR. SUBSEQUENTLY THE PATIENT WAS REFERRED FOR CARDIAC CATHETERIZATION. CORONARY ANGIOGRAPHY REVEALED PATENT STUDY STENT IN DISTAL PORTION OF RCA; JAILED RIGHT POSTERIOR DESCENDING ARTERY (RPDA) WITH 90% DISTAL DISEASE; 60% PROXIMAL DISEASE IN RIGHT POSTEROLATERAL (RPL). THE PATIENT

  Patient problems: Cardiac Enzyme Elevation; Chest Pain; Myocardial Infarction; ST Segment Elevation

  MAUDE report 6293893 ↗