Promus PREMIER™ H7493952816350Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729844747), received between Nov 22, 2016 and Oct 11, 2018 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Break” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 11, 2018Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT MISLABELING OCCURRED. DURING UNPACKING OF AN PROMUS PREMIER STENT, IT WAS NOTICED THAT THE SIZE ON THE PACKAGE (3.5MMX16MM) AND THE DEVICE INSIDE (3.5MMX20MM) DID NOT MATCH. THE DEVICE WAS NOT USED AND A NEW PROMUS PREMIER STENT WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 7957814 ↗
• MalfunctionOct 30, 2017Bent; Bent

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 3.50X16MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, IT WAS NOTED THAT THE STENT WAS DEFECTIVE WHEN IT WAS ADVANCED OVER THE GUIDE WIRE AND FAILED TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6988998 ↗
• MalfunctionFeb 10, 2017Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.50X16MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING ADVANCEMENT, THE SHAFT BROKE. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY AND 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 6321242 ↗
• MalfunctionFeb 7, 2017Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT BALLOON DEFLATION SLOW OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT CIRCUMFLEX ARTERY (LCX). A 3.50X16MM PROMUS PREMIER DRUG ELUTING STENT (DES) WAS ADVANCED TO TREAT THE LESION. THE STENT DELIVERY SYSTEM WAS INFLATED WITH A 50% SALINE AND 50% CONTRAST SOLUTION TO A TOTAL OF 12ML. HOWEVER UPON THE FIRST AND SECOND INFLATIONS, THE BALLOON FAILED TO EXPAND. ON THE THIRD ATTEMPT, THE BALLOON WAS ABLE TO BE INFLATED AND THE STENT WAS SUCCESSFULLY DEPLOYED. POST IMPLANTATION, IT WAS NOTICED THAT THE BALLOON WAS SLOW TO DEFLATE. USING THE INDEFLATOR, IT TOOK FOR 4-5 TIMES IN APPLYING NEGATIVE PRESSURE TO COMPLETELY DEFLATE THE BALLOON. THE DEVICE WAS COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6309406 ↗
• InjuryDec 20, 2016Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGMENT OCCURRED. THE PATIENT PRESENTED WITH NON-ST SEGMENT ELEVATION MYOCARDIAL INFARCTION (NSTEMI), ACTIVE CHEST PAIN, AND ELEVATED TROPONIN LEVELS. THE TARGET LESION WAS LOCATED IN THE TORTUOUS MID RIGHT CORONARY ARTERY (RCA). AFTER TWO PROMUS PREMIER¿ STENTS WERE IMPLANTED, A 3.50X16MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS ADVANCED TO FURTHER TREAT THE LESION. AFTER VIGOROUS ATTEMPTS TO ADVANCE THE STENT, IT WAS DETERMINED THAT THE AREA NEEDED DILATATION. HOWEVER, WHEN REMOVAL OF THE DEVICE WAS ATTEMPTED, THE STENT DISLODGED FROM THE DELIVERY SYSTEM AND REMAINED WEDGED IN THE PROXIMAL RCA. THE DISLODGED STENT WAS ABLE TO BE REMOVED USING A SNARE AFTER REPEATED ATTEMPTS. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE WITH NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS FINE. THE PATIENT HAS BEEN DISCHARGED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6188990 ↗
• MalfunctionNov 29, 2016Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. AFTER PRE-DILATION WAS PERFORMED USING A 2.5X15 NON-BSC BALLOON CATHETER, A 3.50X16MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION AND THE STENT DELIVERY SYSTEM BROKE OFF IN THE GUIDE CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6132387 ↗
• MalfunctionNov 22, 2016Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. AFTER PRE-DILATION WAS PERFORMED USING A 2.5X15 NON-BSC BALLOON CATHETER, A 3.50X16MM PROMUS PREMIER DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION AND THE STENT DELIVERY SYSTEM BROKE OFF IN THE GUIDE CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6121151 ↗