Promus PREMIER™ H7493952832300Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729844976), received between Jan 31, 2017 and Oct 19, 2017 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 19, 2017Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT PERONEAL VESSEL. A 3.00X32MM PROMUS PREMIER STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, DURING PROCEDURE, THE SHAFT DELIVERY SYSTEM BROKE UPON DELIVERY. THE DEVICE WAS THEN RETRIEVED BY PULLING THE DEVICE OUT OF THE BODY OVER THE WIRE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS ALRIGHT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6962637 ↗
• MalfunctionOct 10, 2017Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 3.00X32MM PROMUS PREMIER DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, SHAFT SEPARATION WAS NOTED AFTER STENT DEPLOYMENT. THE STENT DELIVERY SYSTEM, GUIDE CATHETER AND GUIDEWIRE WERE REMOVED. A GUIDE CATHETER WAS REINSERTED AND A THE VESSEL WAS REWIRED. POST DILATION WAS THEN PERFORMED AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6935889 ↗
• MalfunctionJan 31, 2017Bent; Bent

  IT WAS REPORTED THAT STENT DAMAGED OCCURRED. THE TARGET LESION WAS LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA). A 3.0 X 32MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, IT NOTED THAT THE STENT STRUT WAS LIFTED. THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6290242 ↗