Promus PREMIER™ H7493952824250Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729844839), received between Dec 6, 2016 and Aug 6, 2018 — classified as 1 injury, 3 malfunctions.

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

• MalfunctionAug 6, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE DISTAL RIGHT CORONARY ARTERY. A 2.50X24MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION AFTER SEVERAL ATTEMPTS. THE DEVICE WAS REMOVED INTACT FROM THE PATIENT; HOWEVER, WHEN THE DEVICE WAS RE-PREPPING FOR RE-ADVANCED, IT WAS NOTED THAT THE STENT CAME OFF THE BALLOON OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR HARM REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7753377 ↗
• MalfunctionJun 26, 2018Device Damaged Prior to Use; Device Dislodged or Dislocated; Device Damaged Prior to Use; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. A 2.50X24MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS SELECTED FOR USE TO TREAT THE LESION. HOWEVER, IT WAS NOTED THAT THE STENT FELL OFF THE BALLOON. THE DEVICE WAS NOT USED INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS OKAY.

  Patient problems: No Patient Involvement

  MAUDE report 7637856 ↗
• MalfunctionJun 28, 2017Bent; Bent

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE TORTUOUS LEFT ANTERIOR DESCENDING ARTERY (LAD). AFTER ROTABLATION WAS PERFORMED AND A 2.50X16MM STENT WAS IMPLANTED, A 2.50X24MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS ADVANCED; HOWEVER, A LOT OF RESISTANCE WAS ENCOUNTERED. THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY AND THE TIP WAS NOTED TO BE A LITTLE BIT FLARED OUT. THE PROCEDURE WAS COMPLETED WITH ANOTHER 2.50X24MM PROMUS PREMIER¿ DRUG-ELUTING STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6673099 ↗
• InjuryDec 6, 2016Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGMENT OCCURRED. THE TARGET LESION WAS LOCATED IN A SAPHENOUS VEIN GRAFT (SVG) IN A CORONARY ARTERY. A 2.50X24MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION WITH THE USE OF A GUIDEZILLA GUIDE EXTENSION CATHETER. HOWEVER, WHEN THE DEVICE WAS PULLED BACK INTO THE GUIDEZILLA, THE STENT BECAME DISLODGED. ANOTHER STENT WAS THEN ADVANCED AND DEPLOYED, SMASHING THE DISLODGED STENT INTO THE VESSEL WALL, AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6149432 ↗