Promus PREMIER™ H7493952820270Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729844785), received between Oct 12, 2017 and Sep 30, 2019 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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.

• InjurySep 30, 2019Migration; Migration

  IT WAS REPORTED THAT STENT EXPLANTATION OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED MID RIGHT CORONARY ARTERY. A 2.75X20MM PROMUS PREMIER DRUG-ELUTING STENT WAS DEPLOYED TO TREAT THE LESION. HOWEVER, THE STENT STUCK TO THE POST DILATATION BALLOON AND CAME OUT OF THE BODY AFTER DEPLOYMENT. THE PROCEDURE WAS COMPLETED WITH A NEW PROMUS STENT. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9135453 ↗
• MalfunctionApr 10, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.75X20MM PROMUS PREMIER DRUG-ELUTING STENT WAS USED IN A PROCEDURE. HOWEVER, IT WAS NOTED THAT THE SHAFT BROKE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS NOT HARMED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8500893 ↗
• InjuryOct 12, 2017Material Rupture; Activation, Positioning or Separation Problem; Material Rupture; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT BALLOON RUPTURE AND STENT INADEQUATE APPOSITION OCCURRED. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND HEAVILY CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). ROTABLATION WAS PERFORMED WITH A 1.5MM BURR FOLLOWED BY ANOTHER 1.75MM BURR. A 2.75X20MM PROMUS PREMIER DRUG-ELUTING STENT WAS THEN ADVANCED TO TREAT THE LESION. HOWEVER, DURING FIRST INFLATION AT 9 ATMOSPHERES, THE BALLOON RUPTURED. THE STENT WAS DEPLOYED AND BALLOON WAS PULLED NEGATIVE. THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY. SUBSEQUENTLY, ANOTHER NON-BSC BALLOON CATHETER WAS ADVANCED AND DEPLOYED THE STENT SUFFICIENTLY; AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6943836 ↗