Promus PREMIER™ H7493952820350Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729844808), received between Jan 26, 2017 and Dec 15, 2017 — classified as 2 injuries, 2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 15, 2017Bent; Bent

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CALCIFIED, OSTIAL RIGHT CORONARY ARTERY. AFTER PRE-DILATATION WAS PERFORMED USING A 3.5 X 15 MM NC QUANTUM BALLOON CATHETER, A 3.50X20 MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, THE STENT ENGAGED WITH THE CALCIFICATION AND THE DEVICE FAILED TO CROSS THE LESION. THE DEVICE WAS REMOVED AND IT WAS NOTED THAT A STENT STRUT WAS LIFTED. SUBSEQUENTLY, PRE-DILATATION WAS PERFORMED AGAIN 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 7123057 ↗
• MalfunctionOct 11, 2017Entrapment of Device; Entrapment of Device

  SAME CASE AS MDR ID# 2134265-2017-10117. IT WAS REPORTED THAT CATHETER ENTRAPMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). AFTER A CHOICE GUIDEWIRE WAS ADVANCED, A 3.50X20MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS IMPLANTED IN THE LESION. AFTER DEPLOYMENT, THE DELIVERY BALLOON WAS DEFLATED SUCCESSFULLY AND WAS ATTEMPTED TO BE REMOVED; HOWEVER, THE DELIVERY SYSTEM LOCKED UP ON THE WIRE AND HAD TO BE REMOVED AS A UNIT. THE PROCEDURE WAS COMPLETED. POST-PROCEDURE, THE WIRE WAS ABLE TO BE REMOVED FROM THE DELIVERY BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6942248 ↗
• InjuryJul 20, 2017Device Damaged by Another Device; Device Dislodged or Dislocated; Device Damaged by Another Device; Device Dislodged or Dislocated

  SAME CASE AS MDR ID: 2134265-2017-07444. IT WAS REPORTED THAT THE STENT WAS EXPLANTED. THE TARGET LESION WAS LOCATED IN A TORTUOUS AND VERY CALCIFIED LEFT MAIN ARTERY TO RAMUS. A 3.50X20MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS ADVANCED TO THE DISTAL RAMUS HOWEVER; THE LEFT MAIN KEPT PREVENTING THE DEVICE FROM BEING DELIVERED. THE 3.50X20MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS THEN DEPLOYED IN THE LEFT MAIN. A 2.25X12 MM STENT WAS THEN ADVANCED AND SUCCESSFULLY DEPLOYED IN THE DISTAL RAMUS. A 2.25 X 24MM SYNERGY II DRUG-ELUTING STENT WAS THEN ADVANCED BUT HAD DIFFICULTY ADVANCING. A NON-BSC GUIDE EXTENSION WAS CATHETER WAS USED AND THE SYNERGY STENT WAS RE-ADVANCED. HOWEVER, IT WAS NOTED THAT THE PROXIMAL EDGE WAS DAMAGED BY THE NON-BSC GUIDE EXTENSION CATHETER. THE GUIDE EXTENSION CATHETER AND THE SYNERGY STENT WERE REMOVED TOGETHER AND IT WAS NOTED THAT THERE WAS NO STENT ON THE BALLOON. THE STENT HAD STRIPPED OFF ONTO THE LEFT MAIN INSIDE THE PREVIOUSLY IMPLANTED PROMUS PREMIER¿ STENT. A NON-BSC GUIDE WIRE WAS THEN ADVANCED HOWEVER, IT BECAME TANGLED UP WITH THE DISLODGED STENT. THE TANGLED GUIDE WIRE WAS REMOVED HOWEVER BOTH THE DISLODGED SYNERGY STENT AND THE PROMUS PREMIER¿

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6727528 ↗
• InjuryJan 26, 2017Bent; Break; Bent; Break

  IT WAS REPORTED THAT SHAFT BREAK AND STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN A VESSEL IN THE LEFT LOWER EXTREMITY. A 3.50X20MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, UPON ADVANCING, THE PHYSICIAN THOUGHT THAT THE STENT CAME OFF THE BALLOON AND DECIDED TO PULL THE DEVICE BACK. UPON PULLING THE DEVICE, THE CATHETER SHAFT BROKE IN HALF AND THE STENT BALLOON PORTION OF THE CATHETER REMAINED IN THE PATIENT'S BODY. SUBSEQUENTLY, THE REMAINING PORTION OF THE CATHETER WAS REMOVED WITH A SNARE AND AFTER REMOVAL, THE STENT WAS NOTED TO HAVE ACCORDIONED ONTO ITSELF. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6278707 ↗