PROMUS Element™ Plus H7493911412400Recalls & reported problems
Boston Scientific Corporation · Everolimus-Eluting Platinum Chromium Coronary Stent System · Class 3
All models of PROMUS Element Plus (44)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729808060), received between Apr 6, 2017 and Apr 6, 2017 — classified as 1 injury.
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
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Chest Pain1
- Dyspnea1
- Fatigue1
- Occlusion1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 6, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SAME CASE AS MDR IDS: 2134265-2017-03280, 2134265-2017-03281, AND 2134265-2017-03282. (B)(4) CLINICAL STUDY. IT WAS REPORTED THAT CORONARY ARTERY DISEASE, STENOSIS, AND TARGET VESSEL REVASCULARIZATION OCCURRED. IN (B)(6) 2012, THE PATIENT PRESENTED DUE TO UNSTABLE ANGINA. SUBSEQUENTLY, CORONARY ANGIOGRAPHY AND INDEX PROCEDURE WERE PERFORMED. THE TARGET LESION WAS A DE NOVO AND RESTENOTIC LESION LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) WITH 75% STENOSIS AND WAS 10.00MM LONG WITH A REFERENCE VESSEL DIAMETER OF 4.5 MM. THE LESION #2 WAS TREATED WITH DIRECT STENT PLACEMENT USING A 4.00X12.0MM PROMUS ELEMENT¿ PLUS DRUG-ELUTING STUDY STENT, WITH 0% RESIDUAL STENOSIS. A STENT WAS ALSO PLACED IN THE LEFT MAIN CORONARY ARTERY (LMCA). ONE DAY POST PROCEDURE, THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2015, A 3.5X38MM PROMUS ELEMENT STENT WAS IMPLANTED IN THE MID RIGHT CORONARY ARTERY (RCA). FIVE DAYS LATER ANOTHER 3.5X38MM PROMUS ELEMENT WAS IMPLANTED IN THE MID RIGHT CORONARY ARTERY (RCA). IN (B)(6) 2016, A 3.0X28MM SYNERGY MR STENT WAS IMPLANTED IN THE MID RIGHT CORONARY ARTERY (RCA). IN (B)(6) 2017, THE PATIENT PRESENTED TO HOSPITAL WITH SHORTNESS OF BREAT
Patient problems: Chest Pain; Dyspnea; Fatigue; Occlusion
MAUDE report 6463449 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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