Promus PREMIER™ H7493925224400Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729829027), received between Dec 15, 2016 and Dec 15, 2016 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).

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.

• InjuryDec 15, 2016Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED VIA FACILITY MEDWATCH#(B)(6). THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). A 24 X 4.00 PROMUS PREMIER¿ STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, UPON DEPLOYING, THE STENT CAME OFF FROM THE DELIVERY BALLOON AND LODGED IN THE RCA. THE PHYSICIAN WAS ABLE TO REMOVE THE STENT FROM THE PATIENT'S BODY WITH A SNARE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS DISCHARGED TWO DAYS LATER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6176883 ↗
• InjuryDec 15, 2016Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED VIA (B)(4) THAT STENT DISLODGEMENT OCCURRED. IN (B)(6) 2016, LEFT HEART CATHETERIZATION WAS PERFORMED. THE TARGET LESION WAS LOCATED IN THE RADIAL ARTERY. A 24X4.00MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, DURING THE PROCEDURE, THE STENT CAME OFF THE BALLOON RESULTING IN STENT EMBOLIZATION IN THE RADIAL ARTERY. THE PHYSICIAN WAS UNABLE TO REMOVE THE DISLODGED STENT. THE PATIENT AND THE FAMILY WAS MADE AWARE OF THE INCIDENT. BLOOD FLOW TEST WAS DONE AND NO PATIENT COMPLICATIONS WERE NOTED. THE FOLLOWING DAY, THE PATIENT WAS DISCHARGED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6176787 ↗