PROMUS Element™ Plus H7493911432270Recalls & reported problems
Boston Scientific Corporation · Everolimus-Eluting Platinum Chromium Coronary Stent System · Class 3 · Implant
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 08714729823698), received between Oct 27, 2017 and Oct 27, 2017 — classified as 1 injury.
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
Device problems
- Occlusion Within Device1
Patient problems
- Angina1
- Chest Pain1
- Reocclusion1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 27, 2017Occlusion Within Device; Occlusion Within Device
(B)(6) STUDY. IT WAS REPORTED THAT IN-STENT RESTENOSIS (ISR) OCCURRED. IN (B)(6)2012, THE PATIENT WAS REFERRED FOR CARDIAC CATHETERIZATION. SUBSEQUENTLY, CORONARY ANGIOGRAPHY AND THE INDEX PROCEDURE WERE PERFORMED. THE TARGET LESION WAS A DE NOVO LESION LOCATED IN MID RIGHT CORONARY ARTERY (RCA) WITH 99% STENOSIS AND WAS 24.0 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.75MM. THE TARGET LESION WAS TREATED WITH PRE-DILATATION AND STENT PLACEMENT USING A 2.75X32MM PROMUS ELEMENT¿ PLUS STUDY STENT WITH 0% RESIDUAL STENOSIS. ONE DAY POST PROCEDURE, THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL. IN (B)(6) 2017, THE PATIENT PRESENTED WITH COMPLAINTS OF CHEST PAIN AND WAS HOSPITALIZED ON THE SAME DAY. IT WAS REPORTED THAT THE PATIENT HAD TWO EPISODES OF CHEST PAIN WHICH RESOLVED WITH NITROGLYCERIN (NTG) AND THE PATIENT WAS PRESENTED TO EMERGENCY ROOM. ON THE SAME DAY, THE PATIENT WAS DIAGNOSED WITH UNSTABLE ANGINA WITH CANADIAN CLASS 4 SYMPTOMS AFTER MEDICAL EVALUATION, MYOCARDIAL INFARCTION WAS RULED OUT AND THE PATIENT WAS REFERRED FOR A LEFT HEART CATHETERIZATION TO EVALUATION OF ISCHEMIA. DUE TO HER RECURRENT PAIN WHICH WAS REVELED WITH NTG AND HISTORY OF CORONARY ARTERY DISEAS
Patient problems: Angina; Chest Pain; Reocclusion
MAUDE report 6985750 ↗
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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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