Promus PREMIER™ H7493952812270Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729844662), received between May 3, 2018 and Dec 19, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 19, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURED. THE TARGET LESSON WAS LOCATED IN A CORONARY ARTERY. A 2.75X12MM PROMUS PREMIER DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, DURING PROCEDURE, IT WAS NOTED THAT THE STENT WAS BENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8182475 ↗
• MalfunctionMay 3, 2018Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated

  IT WAS FURTHER REPORTED THAT THE CATHETER WAS NOTED TO BE BROKEN INSIDE THE GUIDE CATHETER AFTER THE DEVICE WAS ATTEMPTED TO INFLATE. THE DEVICE WAS COMPLETELY REMOVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7482951 ↗