Promus PREMIER™ H7493952828270Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729844907), received between Feb 6, 2017 and Mar 26, 2018 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Bent” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2018Bent; Entrapment of Device; Device Damaged by Another Device; Bent; Entrapment of Device; Device Damaged by Another Device

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED AND REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 2.75X28MM PROMUS PREMIER STENT WAS ADVANCED TO THE PROXIMAL PART OF THE LESION. HOWEVER, THE DEVICE WAS UNABLE TO CROSS AND DURING REMOVAL OF THE DEVICE, THE STENT WAS HUNG UP ON THE GUIDE CATHETER. IT WAS THEN NOTED THAT THE PROXIMAL EDGE OF THE STENT STRUTS WERE LIFTED AND THE BACK EDGE OF THE STENT WAS STUCK ON THE GUIDE CATHETER, THUS, UNABLE TO REMOVE DEVICE. THE PHYSICIAN REMOVED THE WIRE, GUIDE CATHETER AND THE STENT. RE-WIRING OF THE VESSEL WAS DONE AND THE PROCEDURE WAS COMPLETED WITH IMPLANTATION OF NON-BSC STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7372124 ↗
• InjuryOct 12, 2017Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT STENT PLACEMENT ISSUE OCCURRED. THE TARGET LESION WAS LOCATED IN THE TORTUOUS AND CALCIFIED MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE LESION WAS PRE-DILATED WITH A 2.5X12 APEX BALLOON CATHETER. A 2.75X28MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, DURING DEPLOYMENT, THE ENTIRE STENT DELIVERY SYSTEM WATERMELON SEEDED FORWARD AND THE STENT WAS DEPLOYED A LITTLE DISTAL THAN THE DESIRED LESION AREA. THE RESULT WAS STILL GOOD. THE STENT WAS POST DILATED WITH A 3.0X12 NC QUANTUM BALLOON CATHETER WITH A SUFFICIENT RESULT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6944537 ↗
• MalfunctionAug 1, 2017Bent; Bent

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 2.75X28MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS SELECTED FOR USE TO TREAT THE LESION. HOWEVER, IT WAS NOTED THAT THE STENT STRUTS WERE DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6757541 ↗
• InjuryFeb 9, 2017Bent; Device Damaged by Another Device; Bent; Device Damaged by Another Device

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. DURING A TWO-VESSELS PERCUTANEOUS CORONARY INTERVENTION (PCI), A STENT WAS SUCCESSFULLY DEPLOYED IN THE CIRCUMFLEX (LCX) ARTERY. A 2.75X28MM PROMUS PREMIER¿ DRUG ELUTING STENT WAS ADVANCED OVER A NON-BSC GUIDE WIRE AND WAS SUCCESSFULLY IMPLANTED. HOWEVER, WHEN THE GUIDE WIRE WAS REMOVED, IT WAS NOTED THAT THE DISTAL PORTION OF THE STENT HAD DOUBLE DENSITY APPEARANCE WHICH MAY HAVE BEEN CAUSED BY THE NON-BSC GUIDEWIRE GETTING WRAPPED AROUND THE STENT STRUTS CAUSING DISTAL DEFORMATION. THE STENT WAS RE-WIRED AND A 2.75 PROMUS DRUG ELUTING STENT WAS ADVANCED DISTALLY TO COVER UP THE PORTION OF DEFORMATION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT WAS DOING WELL AND WAS DISCHARGED THE FOLLOWING DAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6314094 ↗
• MalfunctionFeb 6, 2017Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 2.75X28MM PROMUS PREMIER¿ DRUG ELUTING STENT (DES) WAS ADVANCED TO TREAT THE LESION. HOWEVER, THE DEVICE FAILED CROSS THE LESION AND THE SHAFT BROKE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6303240 ↗