Promus PREMIER™ H7493952816300Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729844730), received between Apr 26, 2017 and Jun 10, 2019 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Bent” (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.

• MalfunctionJun 10, 2019Failure to Advance; Defective Device; Failure to Advance; Defective Device

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 15MAY2019. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED AND THE BALLOON AS BULGING AT THE ENDS OF THE STENT. A 3.00X16MM PROMUS PREMIER DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE DEVICE WAS REMOVED AFTER SEVERAL ATTEMPTS AND UPON INSPECTION, IT WAS NOTED THAT THE BALLOON WAS BULGING AT THE END OF THE STENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8682864 ↗
• MalfunctionApr 1, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE TORTUOUS AND CALCIFIED RIGHT CORONARY ARTERY. A 3.00 X 16MM PROMUS PREMIER DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, WHEN PLACING THE STENT, THE PHYSICIAN "FELT A CATCH" AND SO, THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY. THERE WERE NO VISIBLE DAMAGED NOTED UPON INSPECTION. THE PHYSICIAN THEN ADVANCED THE STENT BACK THROUGH THE GUIDE CATHETER BUT COULD NOT SEE THE STENT ON THE BALLOON. THE DEVICE WAS INFLATED AT 3 ATMOPHERES AND WAS CONFIRMED THAT THE STENT WAS NOT ON THE BALLOON. FLOUROSCOPY WAS USED TO EXAMINE THE GUIDE CATHETER AND FOUND OUT THAT THE STENT HAD FALLEN OFF FROM THE BALLOON DURING INSERTION. THE DEVICE WAS REMOVED OUTSIDE THE GUIDE CATHETER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8469324 ↗
• MalfunctionJun 6, 2018Bent; Bent

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN A CALCIFIED CORONARY ARTERY. A 3.00X16MM PROMUS PREMIER¿ DRUG-ELUTING STENT (DES) WAS ADVANCED BUT FAILED TO CROSS THE LESION. IT WAS NOTED THAT ONE OF THE STENT STRUTS IN THE MIDDLE OF THE STENT WAS RAISED. THE DEVICE WAS REMOVED FROM THE PATIENT. THE PHYSICIAN USED A NON-BSC GUIDE EXTENSION CATHETER, ADDITIONAL BALLOONS AND A NEW SAME SIZE PROMUS PREMIER¿ DES WAS PLACED AND 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 7575156 ↗
• MalfunctionDec 22, 2017Bent; Device Damaged Prior to Use; Bent; Device Damaged Prior to Use

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. DURING PREPARATION OF A 3.00X16MM PROMUS PREMIER¿ DRUG-ELUTING STENT, WHEN THE DEVICE WAS REMOVED FROM THE HOOP, IT WAS NOTED THAT THE STENT STRUTS WERE RAISED. THE DEVICE WAS NOT USED AND THE PROCEDURE WAS COMPLETED WITH A 2.75X16MM PROMUS PREMIER¿ DRUG-ELUTING STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 7142793 ↗
• MalfunctionJun 14, 2017Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT CATHETER ENTRAPMENT OCCURRED. THE TARGET LESION WAS LOCATED IN A CLOTTED AND CALCIFIED CORONARY ARTERY. A 3.00X16MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. IT WAS THEN NOTED THAT THE STENT ADHERED TO THE GUIDE WIRE AND COULD NOT BE REMOVED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6641119 ↗
• InjuryMay 10, 2017Difficult to Remove; Device Dislodged or Dislocated; Difficult to Remove; Device Dislodged or Dislocated

  IT WAS REPORTED THAT CATHETER WITHDRAWAL DIFFICULTIES AND STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE DISTAL LEFT MAIN ARTERY. A 3.00X16MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. DURING DELIVERY OF THE DEVICE, THE FRONT EDGE OF THE STENT BECAME TRAPPED WITHIN OSTIAL LEFT ANTERIOR DESCENDING CALCIFICATION AND THE DEVICE WAS UNABLE TO BE ADVANCED OR RETRACTED. THE PHYSICIAN ATTEMPTED TO PULL THE DEVICE BACK FURTHER; HOWEVER, THE STENT STRIPPED OFF OF THE DELIVERY BALLOON. A STENT WITH SMALLER BALLOON WAS TRIED AND THE PROCEDURE WAS COMPLETED. FURTHER MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6556583 ↗
• MalfunctionApr 26, 2017Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A VESSEL IN THE LEFT LEG. A 3.00X16MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, AS THE DEVICE WENT DOWN THE LEG, THE CATHETER BROKE. THE DEVICE WAS THEN COMPLETELY REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6521799 ↗