Promus PREMIER™ H7493952812350Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729844686), received between Feb 16, 2017 and Feb 27, 2019 — classified as 3 injuries, 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 27, 2019Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. A 3.50X12MM PROMUS PREMIER DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, IT FAILED TO CROSS THE LESION AND THE STENT WAS ALTERED UPON WITHDRAWAL. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8375553 ↗
• MalfunctionSep 7, 2017Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 3.50X12 MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE SHAFT OF THE CATHETER GOT FRACTURED. THE PHYSICIAN THOUGHT THAT THE SHAFT GOT FRACTURED WHEN HE TORQUED IT TOO MUCH. THE DEVICE WAS PULLED OUT FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6849511 ↗
• InjuryAug 24, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SAME CASE AS MDR ID: 2134265-2017-08120. IT WAS REPORTED THAT THROMBOSIS OCCURRED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. TWO 3.50X12MM PROMUS PREMIER¿ DRUG ELUTING STENT WERE SELECTED TO TREAT THE LESION, HOWEVER ACUTE THROMBUS WAS NOTED. PROCEDURE WAS COMPLETED WITH AN INTRA-AORTIC BALLOON PUMP. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Thrombosis

  MAUDE report 6816490 ↗
• InjuryAug 24, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SAME CASE AS MDR ID: 2134265-2017-08121. IT WAS REPORTED THAT THROMBOSIS OCCURRED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. TWO 3.50 X 12 MM PROMUS PREMIER¿ DRUG ELUTING STENT WERE SELECTED TO TREAT THE LESION, HOWEVER ACUTE THROMBUS WAS NOTED. PROCEDURE WAS COMPLETED WITH AN INTRA-AORTIC BALLOON PUMP. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Thrombosis

  MAUDE report 6816489 ↗
• InjuryMar 13, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). AFTER A GUIDEWIRE CROSSED THE LESION, A 3.50 X 12 MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS POSITIONED FOR DEPLOYMENT. AS THE PHYSICIAN WAS DEPLOYING THE STENT IN THE OSTIUM RCA, GUIDE CATHETER ACCESS WAS LOST AND THE STENT WAS PARTIALLY DEPLOYED AT THAT POINT. THE PHYSICIAN THEN PULLED THE GUIDE CATHETER AND THE STENT DELIVERY SYSTEM BUT THE STENT CAME OFF FROM THE DELIVERY CATHETER. THE STENT WENT UPSTREAM INTO THE PATIENT AND WAS NO LONGER VISIBLE IN THE RCA. THE PHYSICIAN ADVANCED ANOTHER PROMUS STENT AND SUCCESSFULLY DEPLOYED THE STENT WHICH COMPLETED THE PROCEDURE. THE PATIENT WILL UNDERGO NEUROLOGIC CONSULTATION TO ENSURE IF FURTHER ACTIONS WILL BE REQUIRED BY THE CARDIOLOGIST. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6400897 ↗
• MalfunctionFeb 16, 2017Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.50X12MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS ADVANCED TO TREAT A LESION. HOWEVER, WHILE DEVICE WAS GOING THROUGH THE TUOHY, THE SHAFT BROKE. THE DEVICE WAS REMOVED NORMALLY. THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6337138 ↗