PROMUS Element™ Plus H7493911628270Recalls & 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 08714729807476), received between Apr 13, 2017 and Apr 13, 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
- Anemia1
- Chest Pain1
- Congestive Heart Failure1
- Myocardial Infarction1
- Respiratory Failure1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 13, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
(B)(6). IT WAS REPORTED THAT MYOCARDIAL INFARCTION (MI) OCCURRED. IN (B)(6) 2013, THE PATIENT WAS REFERRED FOR CARDIAC CATHETERIZATION AND THE INDEX PROCEDURE WAS PERFORMED ON THE SAME DAY. THE TARGET LESION WAS LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA) WITH 70% STENOSIS AND WAS 5MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.75MM. THE TARGET LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.75X28MM PROMUS ELEMENT¿ PLUS DRUG-ELUTING STENT, WITH 0% RESIDUAL STENOSIS. THE FOLLOWING DAY, THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2016, THE PATIENT EXPERIENCED CHEST PAIN. THE CHEST PAIN PERSISTED FOR HALF AN HOUR AND DURING THAT TIME, THE PATIENT TOOK NITROGLYCERIN, WHICH RELIEVED THE PAIN TO SOME EXTENT, BUT IT CONTINUED TO PROGRESS. THE PATIENT'S FAMILY REPORTED THAT THE PATIENT WAS SLOWLY AND PROGRESSIVELY HAVING SHORTNESS OF BREATH SINCE TWO WEEKS AGO. THE PATIENT WAS BROUGHT IN AN AMBULANCE. THE PATIENT HAD DIFFICULTY WITH BREATHING AND COULD NOT LIE BACK FLAT WITHOUT HAVING SIGNIFICANT SHORTNESS OF BREATH AND ANXIETY. ON THE SAME DAY, THE PATIENT PRESENTED TO NON-STUDY HOSPITAL AND WAS INTUBATED. THE PATIENT UNDERWENT MULTIPLE LABORATORY EXAMIN
Patient problems: Anemia; Chest Pain; Congestive Heart Failure; Myocardial Infarction; Respiratory Failure
MAUDE report 6490172 ↗
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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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