Promus PREMIER™ H7493952824350Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729844860), received between Jan 30, 2017 and Apr 14, 2017 — classified as 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 14, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 3.50X24MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, DURING THE PROCEDURE, THE STENT WAS STRIPPED OFF BY THE NON-BSC GUIDE EXTENSION CATHETER. SUBSEQUENTLY, THE STENT AND GUIDE EXTENSION CATHETER WERE REMOVED TOGETHER. A SYNERGY STENT WAS THEN ADVANCED, BUT FAILED TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED USING A NON-BSC STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6493084 ↗
• MalfunctionJan 30, 2017Bent; Device Damaged Prior to Use; Bent; Device Damaged Prior to Use

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 3.50X24MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, WHEN THE PACKAGE WAS OPENED, IT WAS NOTED THAT THE DISTAL EDGE OF THE STENT WAS DAMAGED. THE DEVICE WAS NEVER USED INSIDE THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 6287164 ↗