PROMUS Element™ Plus H7493911416270Recalls & 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
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729807896), received between May 10, 2017 and May 10, 2017 — classified as 1 death.
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
- Death1
- Myocardial Infarction1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathMay 10, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SAME CASE AS MDR ID #: 2134265-2017-04402 AND 2134265-2017-04403. IT WAS REPORTED THAT MYOCARDIAL INFARCTION OCCURRED AND THE PATIENT DIED. IN (B)(6) 2013, THE PATIENT PRESENTED DUE TO MYOCARDIAL INFARCTION (MI) AND WAS FURTHER REFERRED FOR CARDIAC CATHETERIZATION. TWO DAYS AFTER, THE INDEX PROCEDURE WAS PERFORMED. THE TARGET LESION WAS A DE NOVO LOCATED IN THE DISTAL LEFT CIRCUMFLEX (LCX) ARTERY WITH 80% STENOSIS AND WAS 32MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.75MM. THE TARGET LESION WAS TREATED WITH PRE-DILATATION AND 2 PROMUS ELEMENT¿ PLUS DRUG-ELUTING STENTS OF 2.50MM X 12MM AND ANOTHER PROMUS ELEMENT¿ PLUS DRUG-ELUTING STENT OF 2.75MM X 16MM WERE SUCCESSFULLY DEPLOYED. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. EIGHT DAYS AFTER, THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2016, PATIENT PRESENTED TO HOSPITAL WITH CHEST PAIN AND PERSISTENT PURULENT DRAINAGE FROM THE UPPER EXTREMITY. PATIENT WAS HOSPITALIZED ON THE SAME DAY. PATIENT WAS PLACED ON A HEPARIN DRIP TO TREAT CHEST PAIN. TWO DAYS AFTER, PATIENT WAS STABLE AND TAKEN TO DIALYSIS. TWO DAYS LATER, PATIENT WAS WEAK AND REFUSED HEMODIALYSIS. AS THE PATIENT WAS STILL WEAK AND HAD ELEVATE
Patient problems: Death; Myocardial Infarction
MAUDE report 6559095 ↗
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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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