Promus PREMIER™ H7493925212400Recalls & reported problems
Boston Scientific Corporation · Everolimus-Eluting Platinum Chromium Coronary Stent System · Class 3
All models of Promus PREMIER (56)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729828846), received between Nov 29, 2016 and Mar 26, 2018 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).
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 18, 2026.
Most reported problems
Device problems
- Device Dislodged or Dislocated2
Patient problems
- No Consequences Or Impact To Patient1
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 26, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. A 12X4.00MM PROMUS PREMIER¿ STENT WAS SELECTED FOR USE. HOWEVER, DURING PREPARATION, THE STENT CAME OFF THE BALLOON DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED USING ANOTHER 12X4.00MM PROMUS PREMIER¿ STENT. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Patient Involvement
MAUDE report 7369523 ↗MalfunctionNov 29, 2016Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT STENT DISLODGMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE DISTAL RIGHT CORONARY ARTERY (RCA). A 12 X 4.00 PROMUS PREMIER¿ DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. DURING REMOVAL OF THE UNDEPLOYED STENT, THE DEVICE CAME OFF THE STENT DELIVERY SYSTEM (SDS) INSIDE THE TOUHY. THE PHYSICIAN REMOVED THE DISLODGED STENT WITH HIS FINGERS. ANOTHER PROMUS PREMIER¿ DRUG-ELUTING STENT WAS ADVANCED BUT STILL FAILED TO CROSS THE LESION. THEN THE PHYSICIAN DECIDED TO STOP THE STENTING IN THE DISTAL RCA LESION AND PERFORMED PERCUTANEOUS CORONARY INTERVENTION OF PROXIMAL RCA LESION. SUBSEQUENTLY, A STENT WAS SUCCESSFULLY IMPLANTED AT THE PROXIMAL RCA AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6133105 ↗
Other Coronary drug-eluting stent devices
- SYNERGY™ H7493926038300Boston Scientific Corporation · Coronary drug-eluting stent8 deaths124 reports
- SYNERGY™ H7493926016300Boston Scientific Corporation · Coronary drug-eluting stent7 deaths106 reports
- SYNERGY™ H7493926020300Boston Scientific Corporation · Coronary drug-eluting stent9 deaths90 reports
- SYNERGY™ H7493926016250Boston Scientific Corporation · Coronary drug-eluting stent6 deaths82 reports
- XIENCE Sierra™ 1550350-33Abbott Vascular Inc. · Coronary drug-eluting stent1 recall32 reports
- Resolute Onyx™ RONYX30022UXMedtronic, Inc. · Coronary drug-eluting stent6 deaths76 reports
- SYNERGY™ H7493926024300Boston Scientific Corporation · Coronary drug-eluting stent3 deaths75 reports
- Resolute Onyx™ RONYX30015UXMedtronic, Inc. · Coronary drug-eluting stent3 deaths73 reports
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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