Promus PREMIER™ H7493952808220Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729844587), received between Mar 17, 2017 and May 27, 2020 — classified as 3 injuries, 1 malfunction.

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.

• InjuryMay 27, 2020Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT THE PATIENT WAS EXPOSED TO EXCESSIVE RADIATION. A 2.25 X 8MM PROMUS PREMIER DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT BUT FAILED TO CROSS THE LESION AND CAUSED A SIGNIFICANT DELAY TO THE PROCEDURE. THIS RESULTED TO PATIENT RECEIVING AN EXCESS RADIATION DOSE EXCEEDING 5 GYCM2. THE SECTION OF THE LESION COULD NOT BE STENTED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Radiation Exposure, Unintended

  MAUDE report 10093735 ↗
• InjuryOct 16, 2017Occlusion Within Device; Occlusion Within Device

  IT WAS REPORTED THAT STENT THROMBOSIS OCCURRED. THE TARGET LESION WAS LOCATED IN THE DISTAL LEFT ANTERIOR DESCENDING ARTERY (LAD). A 2.25 X 8 MM PROMUS PREMIER¿ DRUG ELUTING STENT WAS IMPLANTED IN THE TARGET LESION. AT THE TIME OF THE PLACEMENT, THE ACTIVATED CLOTTING TIME (ACT) WAS 320. THEN, WHEN PHYSICIAN WAS ABOUT TO WORK ON ANOTHER LESION, IT WAS NOTICED THAT THERE WAS A CLOT FORMING ON THE STENT. A MANUAL ASPIRATION CATHETER WAS THEN USED TO REMOVE THE CLOT AND THE ACT WAS 208. THE PROCEDURE WAS COMPLETED AND NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT HAS BEEN DISCHARGED AND WAS OKAY.

  Patient problems: Thrombosis

  MAUDE report 6952474 ↗
• InjuryMay 28, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SAME CASE AS MDR ID: 2134265-2017-04952, 2134265-2017-05707, AND 2134265-2017-05708. IT WAS REPORTED THAT MYOCARDIAL INFARCTION AND FRONTAL LOBE INFARCTION OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT CIRCUMFLEX ARTERY. A 3.00MM X 20MM EMERGE¿ BALLOON CATHETER WAS ADVANCED FOR DILATATION. THE BALLOON WAS INFLATED UP TO 11 ATMOSPHERES; HOWEVER, THE BALLOON DID NOT HOLD PRESSURE. UPON REMOVAL, THE BALLOON WAS NOTED TO BE RUPTURED. ANGIOGRAPHY WAS PERFORMED AND REVEALED A MODERATE SPIRAL DISSECTION OF THE CIRCUMFLEX ARTERY. SUBSEQUENTLY, A 2.25MM X 28MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. A 1.5MM X 8MM EMERGE¿ PUSH BALLOON CATHETER WAS THEN ADVANCED TO RE-DILATE THE ARTERY AND A NON-BSC GUIDE WIRE WAS INSERTED. A 2.25MM X 8MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS THEN DEPLOYED. A 2.25MM X 20MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. THIS WAS FOLLOWED BY A 2.5MM X 12MM PROMUS PREMIER¿ DRUG-ELUTING STENT WHICH WAS DEPLOYED SUCCESSFULLY. LASTLY, A 2.25MM X 8MM REBEL STENT WAS DEPLOYED TO COMPLETE THE CASE. THE PATIENT EXPERIENCED ANEMIA REQUIRING BLOOD TRANSFUSION. THE PATIENT ALSO SUFFERED A RIGH

  Patient problems: Anemia; Cardiac Enzyme Elevation; Cognitive Changes; Myocardial Infarction; Stroke/CVA

  MAUDE report 6596330 ↗
• MalfunctionMar 17, 2017Bent; Bent

  SAME CASE AS MDR ID# 2134265-2017-02338. IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. TWO 2.25 X8MM PROMUS PREMIER¿ DRUG-ELUTING STENTS WERE SELECTED TO TREAT THE LESION. HOWEVER, ON BOTH OCCASIONS, THE STENTS FAILED TO CROSS THE LESION AND WERE NOTED TO BE BENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6413970 ↗