Promus PREMIER™ H7493952820220Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729844761), received between Oct 25, 2017 and Aug 20, 2018 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 20, 2018Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 03-AUG-2018. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.25X20MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED PROXIMAL STENT DAMAGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7796704 ↗
• MalfunctionJan 18, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED VIA USER/FACILITY MEDWATCH# (B)(4) THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY AND RAMUS. A 2.25X20MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE DEVICE WAS UNABLE TO CROSS THE LESION DESPITE SEVERAL ATTEMPTS. EVENTUALLY, THE STENT BECAME DISLODGED AND GOT STUCK INSIDE THE GUIDE HUB. THE DEVICES WERE REMOVED AS A UNIT AND THE DISLODGED STENT WAS RECOVERED FROM THE GUIDE CATHETER. AFTER THE GUIDE CATHETER WAS REMOVED FROM THE PATIENT, THE DISTAL END OF THE GUIDE ABOUT AN INCH FROM THE HUB WAS CUT AND INSERTED THE GUIDE WIRE IN BACKWARDS. THE DISLODGED STENT POPPED OUT AT THE BACK END OF THE GUIDE CATHETER AND THE STENT WAS REMOVED. NO PATIENT COMPLICATIONS WERE REPORTED. ONE DAY POST PROCEDURE, THE PATIENT WAS DISCHARGED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7203283 ↗
• MalfunctionNov 30, 2017Bent; Bent

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED MID LEFT ANTERIOR DESCENDING (LAD) ARTERY AND DISTAL LAD. A STENT WAS SUCCESSFULLY IMPLANTED IN THE MID-LAD. AFTER FURTHER REVIEW, THE PHYSICIAN DECIDED TO DEPLOY, A 2.25X20MM PROMUS PREMIER DRUG-ELUTING STENT IN THE DISTAL-LAD BUT RESISTANCE WAS ENCOUNTERED ACROSS THE PREVIOUSLY IMPLANTED STENT. UPON REMOVAL, IT WAS NOTED THAT THE DISTAL END STENT STRUT WAS FLARED. THE PROCEDURE WAS COMPLETED WITH A NEW 2.25 X 20MM PROMUS PREMIER STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE AND GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7072989 ↗
• MalfunctionNov 3, 2017Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 22-OCT-2017. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED CIRCUMFLEX ARTERY. A 2.25X20MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH A 2.25X16MM STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED PROXIMAL STENT DAMAGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7000365 ↗
• MalfunctionOct 25, 2017Fracture; Fracture

  IT WAS REPORTED THAT STENT FRACTURE OCCURRED. A 2.25X20MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS SELECTED TO TREAT THE LESION. HOWEVER, IT WAS NOTICED THAT A STENT STRUT WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6977513 ↗