PROMUS Element™ Plus H7493911608300Recalls & 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 08714729807582), received between Jun 19, 2017 and Jun 19, 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
- Angina1
- Chest Pain1
- Dyspnea1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 19, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SAME CASE AS MDR: 2134265-2017-06187. (B)(6) CLINICAL STUDY. IT WAS REPORTED THAT UNSTABLE ANGINA OCCURRED. IN (B)(6) 2012, THE PATIENT PRESENTED DUE TO UNSTABLE ANGINA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. SUBSEQUENTLY, INDEX PROCEDURE WAS PERFORMED. THE TARGET LESION WAS A 90% IN-STENT RESTENOSIS OF A PREVIOUSLY IMPLANTED UNSPECIFIED DRUG ELUTING STENT (DES) LOCATED IN THE FIRST OBTUSE MARGINAL (OM1) AND WAS 6.0MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.00MM. THE LESION WAS TREATED WITH DIRECT STENT PLACEMENT USING A 3.00X8MM PROMUS ELEMENT¿ PLUS STUDY STENT, WITH 0% RESIDUAL STENOSIS. ONE DAY POST PROCEDURE, THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2014, A 16 X 2.25MM PROMUS PREMIER¿ DES WAS IMPLANTED IN OM1. IN (B)(6) 2017, THE PATIENT PRESENTED WITH CHEST PAIN ASSOCIATED WITH SHORTNESS OF BREATH. EIGHTEEN DAYS LATER, THE PATIENT WAS PLANNED FOR POSSIBLE CORONARY ARTERY BYPASS GRAFTING (CABG), AS THE PATIENT'S CORONARY INTERVENTION OPTIONS HAS DECREASED. IN (B)(6) 2017, PATIENT WAS HOSPITALIZED FOR THE PLANNED SURGERY. CABG WAS PERFORMED INCLUDING LEFT INTERNAL MAMMARY ARTERY (LIMA) TO DISTAL LEFT ANTERIOR DESCENDING (LAD) AND SAPHENOUS VEIN G
Patient problems: Angina; Chest Pain; Dyspnea
MAUDE report 6652759 ↗
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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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