Promus PREMIER™ H7493952824400Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729844877), received between Nov 30, 2016 and Mar 1, 2019 — classified as 1 injury, 3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 1, 2019Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED BRADYCARDIA. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 4.00MM X 24MM PROMUS PREMIER DRUG-ELUTING STENT WAS ADVANCED AND IMPLANTED IN THE LESION. HOWEVER, IT WAS NOTED THAT THE IMPLANTED STENT WAS EXPIRED. DURING THE PROCEDURE, THE PATIENT EXPERIENCED BRADYCARDIA. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT'S STATUS WAS WELL AND WAS DISCHARGED.

  Patient problems: Bradycardia

  MAUDE report 8381322 ↗
• MalfunctionMar 7, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. A 4.00X24MM PROMUS PREMIER¿ STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, IT WAS NOTED THAT THE STENT GOT DISLODGED FROM THE BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6385094 ↗
• MalfunctionDec 20, 2016Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT CATHETER ENTRAPMENT AND SHAFT BREAK OCCURRED. DURING PREPARATION, A 4.00X24MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS ADVANCED OVER 014 THRUWAY GUIDE WIRE TO TREAT THE LESION. HOWEVER, THE STENT DELIVERY SYSTEM (SDS) BECAME STUCK ON THE WIRE. WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE SDS FROM THE GUIDEWIRE, THE STENT CATHETER BROKE. THE GUIDEWIRE AND THE SDS WERE REMOVED TOGETHER. THE PROCEDURE WAS COMPLETED WITH ANOTHER THRUWAY GUIDEWIRE AND ANOTHER PROMUS PREMIER¿ STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 6190923 ↗
• MalfunctionNov 30, 2016Bent; Device Damaged by Another Device; Bent; Device Damaged by Another Device

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. AFTER A 145 GUIDEZILLA¿ GUIDE EXTENSION CATHETER WAS ADVANCED, A 4.00X24MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, THE PHYSICIAN FELT THAT THE STENT WAS GETTING CAUGHT IN BETWEEN THE GUIDEZILLA¿ AND THE GUIDE CATHETER. THE DEVICE WAS THEN REMOVED AND THE STENT WAS FOUND DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER WITH SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6136020 ↗