Promus PREMIER™ H7493952828220Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729844884), received between Apr 17, 2017 and Feb 27, 2019 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 27, 2019Break; Difficult to Advance; Break; Difficult to Advance

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. FOLLOWING PREDILITATION WITH A 2.0MMX15MM QUANTUM APEX BALLOON, A 2.25X28MM PROMUS PREMIER STENT WAS ADVANCED FOR TREATMENT. HOWEVER, IT FAILED TO CROSS THE LESION AND THE SHAFT BROKE. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8376395 ↗
• MalfunctionFeb 8, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.25X28MM PROMUS PREMIER DRUG ELUTING STENT WAS ADVANCEED FOR DILATION. HOWEVER, IT WAS FOUND THAT THE SHAFT BROKE. THE PROCEDURE WA COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS NOR INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8323479 ↗
• InjuryFeb 9, 2018Migration or Expulsion of Device; Device Dislodged or Dislocated; Migration or Expulsion of Device; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A STENT DISLODGED AND WAS SURGICALLY REMOVED. THE TARGET LESION WAS A CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.25 X 28MM PROMUS PREMIER¿ STENT WAS ADVANCED AND HAD DIFFICULTY CROSSING THE LESION. A LITTLE FORCE WAS USED AND THEN THE BALLOON PARTIALLY CAME OFF THE BALLOON. THE STENT DELIVERY SYSTEM AND STENT WERE STILL ON THE GUIDEWIRE; THE PHYSICIAN INTENDED TO PULL THE ENTIRE SYSTEM WITH THE GUIDEWIRE INTO THE GUIDE CATHETER AND REMOVE EVERYTHING FROM THE BODY. UPON DOING THIS, THE STENT BECAME FURTHER DISLODGED AND EMBOLIZED. THE PATIENT WAS X-RAYED AND THE STENT HAD MIGRATED TO THE PATIENT'S ANKLE. THE PATIENT WAS TRANSPORTED TO THE INTERVENTIONAL RADIOLOGY LAB WHERE A VASCULAR SURGEON REMOVED THE STENT. THERE WERE NO FURTHER PATIENT COMPLICATIONS AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7259162 ↗
• InjuryApr 19, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE CIRCUMFLEX ARTERY. A 2.25X28MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, DURING THE PROCEDURE, THE STENT WAS DISLODGED OFF THE DELIVERY SYSTEM. THE DISLODGED STENT WAS RETRIEVED USING A SNARING DEVICE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH IMPLANTATION OF MORE STENTS. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6503144 ↗
• InjuryApr 17, 2017Difficult to Remove; Device Dislodged or Dislocated; Difficult to Remove; Device Dislodged or Dislocated

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES WERE ENCOUNTERED AND STENT DISLODGEMENT OCCURRED. AFTER A GUIDE CATHETER WAS PLACED, A 2.25X28MM PROMUS PREMIER¿ DRUG ELUTING STENT WAS INTRODUCED TO TREAT THE LESION. HOWEVER, IT WAS NOTED ON THE EXIT OF THE CATHETER, THE STENT DID NOT ¿LOOK¿ CORRECT. AT SOME POINT, THE STENT WOULD NOT ADVANCE, AND THE PHYSICIAN ATTEMPTED TO PULL THE STENT BACK INTO THE GUIDE CATHETER. HOWEVER, THE DEVICE FAILED TO MOVE. AFTER CONTINUALLY TRYING, THE STENT WAS DETACHED FROM THE BALLOON AND STENT DELIVERY SYSTEM (SDS). THE SDS WAS REMOVED AND A SNARE WAS INTRODUCED. THE DETACHED STENT WAS SNARED BACK INTO THE GUIDE CATHETER AND THE DEVICE WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6497239 ↗