Promus PREMIER™ H7493952828250Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729844891), received between Dec 6, 2016 and Feb 5, 2018 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (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

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 5, 2018Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 2.50X28MM PROMUS PREMIER¿ STENT WAS ADVANCED FOR DILATION. HOWEVER, THE SHAFT BROKE AT ABOUT 6 INCHES FROM THE HUB OUTSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7241843 ↗
• MalfunctionNov 1, 2017Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. AFTER A GUIDE CATHETER WAS PLACED, A 2.50X28MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION; HOWEVER, DURING THE PROCEDURE, THE SHAFT WAS BROKEN. THE STENT WAS REMOVED INTACT TOGETHER WITH THE GUIDE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS NOR HARM WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6992957 ↗
• MalfunctionFeb 6, 2017Bent; Device Dislodged or Dislocated; Bent; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DAMAGE AND STENT MOVE ON BALLOON OCCURRED. A 2.50X28MM PROMUS PREMIER¿ DRUG ELUTING STENT WAS SELECTED FOR USE. HOWEVER DURING THE PROCEDURE, THE STENT WAS NOTED TO BE FLARED AND PARTIALLY PULLED OFF FROM THE STENT DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED WITH ANOTHER STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6304054 ↗
• InjuryDec 6, 2016Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE DISTAL RIGHT CORONARY ARTERY (RCA). AFTER A NON-BSC DEVICE CAUSED A PROXIMAL DISSECTION IN THE RCA, A 3.0MM X12MM AND A 2.5MM X 28MM PROMUS PREMIERS STENT WAS SUCCESSFULLY IMPLANTED IN THE RCA TO COVER A DISSECTION. SUBSEQUENTLY, ANOTHER 2.50X28MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS ADVANCED AND WAS ATTEMPTED TO BE DEPLOYED DISTALLY TO THE PREVIOUS STENTS. HOWEVER, THE DEVICE FAILED TO CROSS THE TWO PREVIOUSLY IMPLANTED STENTS. UPON RETRIEVING, THE STENT GOT DISLODGED AND HAD TO BE CRUSHED INTO THE RCA WALL WHERE THE TWO STENTS WERE IMPLANTED. THE DISTAL PORTION OF THE SPIRAL DISSECTION WAS NOT COVERED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6149447 ↗