PROMUS Element™ Plus H7493911612250Recalls & 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 08714729807353), received between Dec 12, 2016 and Dec 12, 2016 — 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
- Occlusion1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 12, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SAME CASE AS MDR ID# 2134265-2016-11767. (B)(4). IT WAS REPORTED THAT RESTENOSIS OCCURRED. IN (B)(6) 2012, THE PATIENT PRESENTED WITH UNSTABLE ANGINA AND MYOCARDIAL INFARCTION (MI). SUBSEQUENTLY, CORONARY ANGIOGRAPHY WAS PERFORMED. TARGET LESION #1 WAS A DE NOVO LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH 100% STENOSIS AND WAS 15MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5MM. TARGET LESION #1 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.50X20MM PROMUS ELEMENT¿ PLUS DRUG-ELUTING STENT, WITH 0% RESIDUAL STENOSIS. TARGET LESION #2 WAS A DE NOVO LESION LOCATED IN THE MID LAD WITH 80% STENOSIS AND WAS 10MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5MM. TARGET LESION #2 WAS TREATED WITH DIRECT PLACEMENT OF A 2.50X12MM PROMUS ELEMENT¿ PLUS DRUG-ELUTING STENT, WITH 0% RESIDUAL STENOSIS. THREE DAYS LATER, THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2015, THE PATIENT WAS DIAGNOSED WITH CORONARY ARTERY DISEASE AND WAS HOSPITALIZED ON THE SAME DAY. SUBSEQUENTLY, CORONARY ANGIOGRAPHY WAS PERFORMED WHICH REVEALED AN 80% OCCLUSION IN THE MID SEGMENT OF THE LAD. ON THE SAME DAY, THE PATIENT UNDERWENT CORONARY ARTERY BYPASS GRAFT (CABG) INCL
Patient problems: Occlusion
MAUDE report 6167429 ↗
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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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