Promus PREMIER™ H7493952812300Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08714729844679), received between Nov 15, 2016 and Apr 5, 2019 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Bent” (4 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryApr 5, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGMENT OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE RADIAL ARTERY. THE TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND HEAVY CALCIFIED LEFT CIRCUMFLEX ARTERY. A 3.00X12MM PROMUS PREMIER DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE STENT CAME OFF THE BALLOON AND LODGED IN THE ARM WHICH WAS THEN RETRIEVED BY SNARING. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8487155 ↗
• MalfunctionApr 4, 2018Bent; Bent

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE PATIENT PRESENTED WITH ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 3.00X12MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, WHEN THE DEVICE WAS ADVANCED THROUGH THE GUIDING CATHETER, IT WAS UNABLE TO ADVANCE INTO THE CORONARY SYSTEM AND WAS REMOVED. WHEN THE PHYSICIAN RE-ADVANCED THE DEVICE, IT WAS NOTED THAT A STRUT WAS STICKING UP. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7396184 ↗
• MalfunctionOct 27, 2017Bent; Bent

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 3.00X12MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE STENT STRUTS WERE BROKEN. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6983657 ↗
• MalfunctionOct 25, 2017Bent; Bent

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE HEAVILY CALCIFIED RIGHT CORONARY ARTERY (RCA). A 3.00 X 12 MM PROMUS PREMIER¿ STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE DEVICE WAS REMOVED AND IT WAS NOTED THAT THE PROXIMAL PART OF THE STENT GOT FLARED. THE PROCEDURE WAS COMPLETED WITH A NEW 3.0 X 12 PROMUS PREMIER STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS WAS GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6977438 ↗
• MalfunctionAug 28, 2017Material Deformation; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 08-AUG-2017. IT WAS REPORTED THAT SHAFT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 3.00X12MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, DURING DELIVERY, IT WAS NOTED THAT THE SHAFT WAS DAMAGED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A HYPOTUBE BREAK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6824741 ↗
• MalfunctionMar 17, 2017Break; Break

  SAME CASE AS MDR ID # 2134265-2017-02402. IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A VEIN GRAFT TO THE LEFT ANTERIOR DESCENDING ARTERY (LAD). A 3.00X12MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, THE CATHETER SHAFT BECAME SLIGHTLY KINKED AND AS THE DEVICE WAS ADVANCED FURTHER, THE CATHETER FRACTURED. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY AND A SECOND 3.00X12MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS ADVANCED. HOWEVER, THE DEVICE HUNG UP IN THE VESSEL AND WAS UNABLE TO ADVANCE INTO THE LESION. THE DEVICE WAS REMOVED AND IT WAS NOTED THAT THE STENT WAS DAMAGED. THE STENT SEEMED TO BE FRAYED AND LIFTED FROM THE DELIVERY SYSTEM BUT STILL ON THE DELIVERY SYSTEM. A THIRD 3.00X12MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS ADVANCED AND SUCCESSFULLY DEPLOYED, AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6414724 ↗
• MalfunctionMar 17, 2017Bent; Bent

  SAME CASE AS MDR ID # 2134265-2017-02401. IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN A VEIN GRAFT TO THE LEFT ANTERIOR DESCENDING ARTERY (LAD). A 3.00X12MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, THE CATHETER SHAFT BECAME SLIGHTLY KINKED AND AS THE DEVICE WAS ADVANCED FURTHER, THE CATHETER FRACTURED. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY AND A SECOND 3.00X12MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS ADVANCED. HOWEVER, THE DEVICE HUNG UP IN THE VESSEL AND WAS UNABLE TO ADVANCE INTO THE LESION. THE DEVICE WAS REMOVED AND IT WAS NOTED THAT THE STENT WAS DAMAGED. THE STENT SEEMED TO BE FRAYED AND LIFTED FROM THE DELIVERY SYSTEM, BUT STILL ON THE DELIVERY SYSTEM. A THIRD 3.00X12MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS ADVANCED AND SUCCESSFULLY DEPLOYED, AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6414695 ↗
• MalfunctionJan 13, 2017Kinked; Difficult to Advance; Kinked; Difficult to Advance

  REPORTABLE BASED ON ANALYSIS COMPLETED ON 19-DEC-2016. IT WAS REPORTED ADVANCING DIFFICULTIES WERE ENCOUNTERED AND SHAFT KINK OCCURRED. A 3.00X12MM PROMUS PREMIER¿ DRUG ELUTING STENT WAS SELECTED TO TREAT THE LESION. DURING PREPARATION, THE PHYSICIAN ATTEMPTED TO INSERT THE DEVICE THROUGH A NON-BSC GUIDE CATHETER, HOWEVER, THE NON-BSC GUIDE CATHETER WAS KINKED AND THE STENT DELIVERY SYSTEM (SDS) WAS UNABLE TO PASS THROUGH. UPON REMOVAL OF THE SDS, IT WAS NOTICED THAT THE SHAFT WAS KINKED AT THE WIRE EXIT PORT. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGE AND STENT MOVED ON BALLOON.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6249172 ↗
• MalfunctionDec 16, 2016Fracture; Fracture

  IT WAS REPORTED THAT SHAFT FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE TORTUOUS AND EXTREMELY CALCIFIED RIGHT CORONARY ARTERY (RCA). A 3.00X12MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. AFTER SEVERAL ATTEMPTS TO CROSS THE LESION, THE STENT DELIVERY CATHETER PARTIALLY FRACTURED. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY AND FURTHER PRE-DILATATION WAS PERFORMED. ANOTHER PROMUS PREMIER¿ STENT WAS THEN IMPLANTED AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6182757 ↗
• MalfunctionNov 15, 2016Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.00X12MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, DURING INTRODUCTION, THE SHAFT WAS BROKEN AND HAD TO PULL THE DEVICE OUT. THE PROCEDURE WAS COMPLETED USING ANOTHER 3.00X12MM PROMUS PREMIER¿ STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6101420 ↗