Promus PREMIER™ H7493952808350Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729844624), received between May 9, 2017 and Jul 11, 2017 — classified as 1 injury, 1 malfunction.

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.

• MalfunctionJul 11, 2017Bent; Bent

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 3.50X8MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. HOWEVER, THE PHYSICIAN NOTED THAT THE STENT STRUT WAS DAMAGED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6701454 ↗
• InjuryMay 9, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE VERY CALCIFIED PROXIMAL RIGHT CORONARY ARTERY (RCA). AFTER PRE-DILATION WAS PERFORMED, A 3.50X8MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. HOWEVER, UPON REMOVAL OF THE DEVICE AND WHEN A GUIDEZILLA GUIDE EXTENSION CATHETER WAS INSERTED, IT WAS NOTED THAT THE STENT HAD FALLEN OFF OF THE BALLOON INSIDE THE RCA. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL. NO FURTHER COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6553714 ↗