Promus PREMIER™ H7493952828400Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729844938), received between Jun 21, 2017 and Oct 17, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 17, 2018Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). A 4.00X 28MM PROMUS PREMIER STENT AND A 4.00X 32MM SYNERGY STENT WERE ATTEMPTED TO BE USED DURING THE PROCEDURE; HOWEVER, THE PROXIMAL ENDS OF THE DEVICES SNAPPED DURING INTRODUCTION THROUGH THE NON-BSC GUIDE CATHETER. ANOTHER 4.00X 32MM SYNERGY STENT WAS THEN USED AND COMPLETED THE PROCEDURE WITH AN EXCELLENT RESULT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7974800 ↗
• MalfunctionJun 21, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). A 4.00X28MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, DURING THE PROCEDURE, THE STENT DISLODGED FROM THE STENT DELIVERY SYSTEM. SUBSEQUENTLY, THE DETACHED STENT WAS RETRIEVED WITH THE WHOLE SYSTEM AS ONE UNIT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6656660 ↗