Promus PREMIER™ H7493952812250Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729844655), received between Dec 15, 2016 and May 26, 2020 — classified as 3 injuries, 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMay 26, 2020Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT THE PATIENT WAS EXPOSED TO EXCESSIVE RADIATION. A 2.50 X 12MM PROMUS PREMIER DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION AND CAUSES A SIGNIFICANT DELAY TO THE PROCEDURE. THIS RESULTED TO PATIENT RECEIVING AN EXCESS RADIATION DOSE EXCEEDING 5 GYCM2. THE SECTION OF THE LESION COULD NOT BE STENTED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Radiation Exposure, Unintended

  MAUDE report 10088280 ↗
• InjuryMay 7, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN A SEVERELY TORTUOUS CORONARY ARTERY. A 2.50X12MM PROMUS PREMIER¿ DRUG ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, THE DEVICE FAILED TO CROSS THE LESION DESPITE MULTIPLE ATTEMPTS AND THE STENT CAME OFF THE BALLOON. THE STENT LODGED INTO THE CIRCUMFLEX ARTERY AND WAS UNABLE TO BE REMOVED. THE PATIENT WAS THEN SENT FOR CORONARY ARTERY BYPASS GRAFT AND THE OBTUSE MARGINAL BRANCHES OF THE CIRCUMFLEX ARTERY WERE SURGICALLY GRAFTED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7491400 ↗
• MalfunctionDec 8, 2017Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE PRODUCT WAS MISLABELED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. AFTER BALLOON ANGIOPLASTY WAS PERFORMED USING A 2.0X8MM BALLOON CATHETER, A 2.50X12MM PROMUS PREMIER DRUG-ELUTING STENT WAS IMPLANTED AND WAS FULLY APPOSED. HOWEVER, IT WAS NOTED THAT THE STENT SIZE WAS ACTUALLY 2.5X16MM WHICH WAS VERIFIED BY A 2.5X15MM NC EMERGE BALLOON CATHETER NOTED UNDER FLUOROSCOPY. THE STENT WAS LABELED AND PACKAGED WRONG. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7101828 ↗
• MalfunctionOct 19, 2017Bent; Difficult to Remove; Failure to Advance; Bent; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT CATHETER REMOVAL DIFFICULTIES WERE ENCOUNTERED AND STENT DAMAGE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED FIRST DIAGONAL BRANCH. A 2.50X12MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE PHYSICIAN HAD A HARD TIME REMOVING THE DEVICE AND ONCE COMPLETELY REMOVED, IT WAS NOTED THAT THE DISTAL PORTION OF THE STENT STRUTS WAS MANGLED. AFTER REMOVAL OF THE DEVICE, PRE-DILATATION WAS PERFORMED WITH A 2.5X15MM EMERGE BALLOON CATHETER AND A 2.5X8MM PROMUS STENT WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6962607 ↗
• MalfunctionSep 15, 2017Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.50X12MM PROMUS PREMIER¿ DRUG ELUTING STENT WAS SELECTED FOR USE. HOWEVER, PRIOR TO INTRODUCTION, IT WAS NOTED THAT THE SHAFT BROKE OUTSIDE THE PATIENT'S BODY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER 2.50X12MM PROMUS PREMIER¿ STENT. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 6868184 ↗
• InjuryMay 28, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SAME CASE AS MDR ID: 2134265-2017-04952, 2134265-2017-05706, AND 2134265-2017-05708. IT WAS REPORTED THAT MYOCARDIAL INFARCTION AND FRONTAL LOBE INFARCTION OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT CIRCUMFLEX ARTERY. A 3.00MM X 20MM EMERGE¿ BALLOON CATHETER WAS ADVANCED FOR DILATATION. THE BALLOON WAS INFLATED UP TO 11 ATMOSPHERES; HOWEVER, THE BALLOON DID NOT HOLD PRESSURE. UPON REMOVAL, THE BALLOON WAS NOTED TO BE RUPTURED. ANGIOGRAPHY WAS PERFORMED AND REVEALED A MODERATE SPIRAL DISSECTION OF THE CIRCUMFLEX ARTERY. SUBSEQUENTLY, A 2.25MM X 28MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. A 1.5MM X 8MM EMERGE¿ PUSH BALLOON CATHETER WAS THEN ADVANCED TO RE-DILATE THE ARTERY AND A NON-BSC GUIDE WIRE WAS INSERTED. A 2.25MM X 8MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS THEN DEPLOYED. A 2.25MM X 20MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. THIS WAS FOLLOWED BY A 2.5MM X 12MM PROMUS PREMIER¿ DRUG-ELUTING STENT WHICH WAS DEPLOYED SUCCESSFULLY. LASTLY, A 2.25MM X 8MM REBEL STENT WAS DEPLOYED TO COMPLETE THE CASE. THE PATIENT EXPERIENCED ANEMIA REQUIRING BLOOD TRANSFUSION. THE PATIENT ALSO SUFFERED A RIGH

  Patient problems: Anemia; Cardiac Enzyme Elevation; Cognitive Changes; Myocardial Infarction; Stroke/CVA

  MAUDE report 6596321 ↗
• MalfunctionDec 15, 2016Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT MOVED ON BALLOON. THE TARGET LESION WAS LOCATED IN THE VERY TIGHT SAPHENOUS VEIN GRAFT. A 2.50X12MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, WHILE ADVANCING THE DEVICE THRU THE LESION, THE PHYSICIAN NOTED THAT THE STENT WAS SLIDING OFF THE BALLOON. EVENTUALLY, THE STENT WAS PLACED OVER THE LESION IN THE DESIRED POSITION 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 6176685 ↗