Promus PREMIER™ H7493952808300Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729844617), received between Dec 12, 2017 and Oct 10, 2018 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Bent” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 10, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. DURING PREPARATION, THE PHYSICIAN USED A 3.00X8MM PROMUS PREMIER DRUG-ELUTING STENT, HOWEVER WHILE PREPARING THE DISTAL END PART WAS MANGLED BY THE PHYSICIAN. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7951501 ↗
• InjuryFeb 27, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN A RIGHT CORONARY ARTERY. A 3.00X8MM PROMUS PREMIER DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, THE STENT CAME OFF THE DELIVERY BALLOON PREMATURELY. A SNARE WAS THEN USED TO CAPTURE THE STENT FROM THE ARTERY. THE PROCEDURE WAS COMPLETED WITH ANOTHER PROMUS PREMIER DRUG-ELUTING STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7299236 ↗
• MalfunctionDec 12, 2017Bent; Device Damaged Prior to Use; Bent; Device Damaged Prior to Use

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. DURING PREPARATION OF A 3.00X8MM PROMUS PREMIER¿ DRUG-ELUTING STENT, IT WAS NOTED THAT THE STENT WAS DAMAGED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Patient Involvement

  MAUDE report 7110594 ↗