PROMUS Element™ Plus H7493911628350Recalls & reported problems
Boston Scientific Corporation · Everolimus-Eluting Platinum Chromium Coronary Stent System · Class 3
All models of PROMUS Element Plus (44)
Data updated Oct 18, 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 08714729807636), received between Aug 8, 2018 and Aug 8, 2018 — 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 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Reocclusion1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT RESTENOSIS OCCURRED. IN (B)(6) 2012, THE PATIENT PRESENTED WITH UNSTABLE ANGINA AND ST-SEGMENT ELEVATION INFERIOR WALL MYOCARDIAL INFARCTION. SUBSEQUENTLY, CORONARY ANGIOGRAPHY AND THE INDEX PROCEDURE WAS PERFORMED. TARGET LESION WAS A DE NOVO AND CULPRIT LESION FOR STEMI LOCATED IN MID RIGHT CORONARY ARTERY (RCA) WITH 99% STENOSIS AND TIMI FLOW 1. IT WAS 22MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.50MM. THE TARGET LESION WAS TREATED WITH PRE-DILATATION USING 2.5 X 20MM EMERGE BALLOON CATHETER AND A 3.0 X 20MM EMERGE BALLOON, FOLLOWED BY A 3.50 X 28MM PROMUS ELEMENT PLUS DRUG-ELUTING STENT, WHICH WAS PLACED WITH 0% RESIDUAL STENOSIS AND TIMI 3 FLOW. AFTER TWO DAYS, THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2014, THE PATIENT PRESENTED IN CARDIOLOGY DEPARTMENT FOR FOLLOW-UP CARE WITH COMPLAINS OF CHEST PAIN IN THE MIDDLE OF THE CHEST WITH SOME RADIATION TOWARDS LEFT SHOULDER WITH EXERTION. THE PATIENT STATED THAT THE PAIN WAS NOTICED WHILE USING ARMS AND IT RESOLVED AFTER 1-2 MINUTES WITH REST. SUBSEQUENTLY, THE PATIENT WAS SCHEDULED FOR A LEFT HEART CATHETERIZATION ELEVEN DAYS LATER. THE 99% SEVERE SUBTOTAL PROXIMAL OCCLUSION LOCATED J
Patient problems: Reocclusion
MAUDE report 7764922 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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