Promus PREMIER™ H7493952816220Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729844709), received between Sep 5, 2017 and Dec 20, 2019 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Bent” (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.

• MalfunctionDec 20, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED AT THE LEFT CORONARY ARTERY. A 2.25X16MM PROMUS PREMIER DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION AND IT WAS NOTED THAT THE UNDEPLOYED STENT WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9501330 ↗
• MalfunctionFeb 13, 2018Bent; Bent

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CIRCUMFLEX ARTERY. A 2.25X16 MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, THE DEVICE FAILED TO CROSS THE LESION AND THE STENT WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7266397 ↗
• MalfunctionDec 13, 2017Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED RAMUS ARTERY. A 2.25X16MM PROMUS PREMIER STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, THE DEVICE FAILED TO CROSS AND IT WAS NOTED THAT THE SHAFT BROKE AT ABOUT 100CM FROM THE HUB. THE DEVICE WAS COMPLETELY REMOVED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS DISCHARGED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7116259 ↗
• InjuryOct 25, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT VESSEL DISSECTION OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 2.25X16MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. HOWEVER, A VESSEL DISSECTION WAS NOTED. THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Vascular Dissection

  MAUDE report 6976527 ↗
• MalfunctionOct 9, 2017Bent; Bent

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN A HIGHLY CALCIFIED CORONARY ARTERY. A 2.25X16MM PROMUS PREMIER¿ STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE DEVICE WAS REMOVED AND IT WAS NOTED THAT THE STENT STRUTS WERE LIFTED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS WAS OKAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6929346 ↗
• InjurySep 5, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. A 2.25X16MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS. MOREOVER, UPON ATTEMPTING TO REMOVE THE DEVICE, THE STENT SHEARED OFF ON THE WIRE. THE PHYSICIAN THEN ADVANCED THE BALLOON AND SUCCESSFULLY RETRIEVE THE STENT. THE PROCEDURE WAS COMPLETED WITH A 2.0X16MM NON-BSC BARE METAL STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6841778 ↗