Promus PREMIER™ H7493952816400Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729844754), received between Nov 18, 2016 and Sep 5, 2017 — classified as 4 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

Recent adverse event reports

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

• MalfunctionSep 5, 2017Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 24-AUG-2017. IT WAS REPORTED THAT DIFFICULTY CROSSING THE LESION OCCURRED. A 4.00X16MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE TARGET LESION. HOWEVER, IT FAILED TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DETACHED/SEPARATED AND STENT DAMAGED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6842830 ↗
• MalfunctionMar 7, 2017Bent; Bent

  SAME CASE AS MDR ID: 2134265-2017-01671 IT WAS REPORTED THAT THE STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). A 4.00X32MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, DURING THE PROCEDURE, THE STENT BUNCHED UP IN THE MIDDLE OF THE BALLOON AND SLID A COUPLE OF MILLIMETERS OFF THE END OF THE BALLOON. THE PROXIMAL END OF THE STENT WAS HALF WAY DOWN THE BALLOON. TO PREVENT THE STENT TO BE DISLODGED FROM THE BALLOON, THE PHYSICIAN DEPLOYED THE STENT TO WHERE IT WAS. THE PHYSICIAN THEN DILATED THE FIRST STENT AFTER IT WAS DEPLOYED. THE PHYSICIAN ADVANCED A 4.00X16MM PROMUS PREMIER¿ DRUG-ELUTING STENT BUT THERE WAS DIFFICULTY PASSING THROUGH THE FIRST DEPLOYED STENT. WHILE PULLING THE SECOND STENT OUT, IT HUNG UP ON THE FIRST STENT AND THE FIRST STENT HUNG UP ON THE GUIDE. THE SECOND STENT HAD A BURR IN THE MIDDLE OF THE STENT. A NON-BSC GUIDE EXTENSION CATHETER WAS THEN ADVANCED AND ANOTHER PROMUS STENT WAS DELIVERED WHICH COMPLETED THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6385244 ↗
• MalfunctionJan 18, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGMENT OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 4.00X16MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, THE STENT SEPARATED FROM THE DELIVERY SYSTEM INSIDE THE GUIDE CATHETER. THE DELIVERY SYSTEM WAS PULLED OUT AND THEY WERE ABLE TO GET THE STENT OUT AS WELL. 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 6262182 ↗
• MalfunctionNov 18, 2016Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE PROXIMAL CIRCUMFLEX ARTERY. A 4.00X16MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, WHILE ATTEMPTING TO IMPLANT THE DEVICE, THE STENT CAME OFF FROM THE STENT DELIVERY SYSTEM (SDS) IN THE LEFT MAIN (LM) ARTERY AND WAS FOUND IN THE TUOHY OF THE NON-BSC GUIDE CATHETER. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6112800 ↗